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PubMed2000

Intravenous immunoglobulin for preventing infection in preterm and/or low-birth-weight infants.

BACKGROUND: Nosocomial infections continue to be a significant cause of morbidity and mortality among preterm and/or low birth weight infants. Maternal transport of immunoglobulins to the fetus mainly occurs after 32 weeks gestation and endogenous synthesis does not begin until several months after birth. Administration of intravenous immunoglobulin provides IgG that can bind to cell surface receptors, provide opsonic activity, activate complement, promote antibody dependent cytotoxicity, and improve neutrophilic chemoluminescence. Intravenous immunoglobulin thus has the potential of preventing or altering the course of nosocomial infections. OBJECTIVES: To assess the effectiveness/safety of intravenous immunoglobulin (IVIG) administration (compared to placebo or no intervention) to preterm (< 37 weeks gestational age at birth) and/or low birth weight (LBW) (< 2500 g BW) infants in preventing nosocomial infections. SEARCH STRATEGY: Medline, Embase, Cochrane Library and Reference Update Databases were searched in November 1997 using keywords: immunoglobulin and infant-newborn and random allocation or controlled trial or randomized controlled trial (RCT). The reference lists of identified RCTs, personal files and Science Citation Index were searched. No language restrictions were applied. SELECTION CRITERIA: The criteria used to select studies for inclusion in this overview were: 1) DESIGN: RCTs in which administration of IVIG was compared to a control group that received a placebo or no intervention. 2) POPULATION: preterm (< 37 weeks gestational age) and/or LBW (<2500 g) infants. 3) INTERVENTION: IVIG for the prevention of bacterial/fungal infection during initial hospital stay (8 days or longer). (Studies that were primarily designed to assess the effect of IVIG on humoral immune markers were excluded as were studies in which the follow-up period was one week or less). 4) At least one of the following outcomes was reported: sepsis, any serious infection, death from all causes, death from infection, length of hospital stay, intraventricular haemorrhage (IVH), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD). DATA COLLECTION AND ANALYSIS: Two reviewers independently abstracted information for each outcome reported in each study, and one researcher (AO) checked for any discrepancies and pooled the results. Relative risk (RR) and Risk Difference (RD) with 95% confidence intervals (CI) using the fixed effects model are reported. When a statistically significant RD was found the number needed to treat (NNT) was also calculated with 95% CIs. The results include all accepted studies in which the outcome of interest was reported. When statistically significant heterogeneity was found for an outcome, secondary (sensitivity) analyses were performed including only studies of the highest quality. MAIN RESULTS: Fifteen studies met inclusion criteria. These included 5,054 preterm and/or LBW infants and reported on at least one of the outcomes of interest for this systematic review. When all studies were combined there was a statistically significant reduction in sepsis, one or more episodes [RR 0.83 (95% CI 0.72, 0.97); RD -0.028 (95% CI -0.006, -0.051); NNT 36 (95% CI 20, 167)]. There was significant between-study heterogeneity. When, in a sensitivity analysis, the high quality studies were combined, the results remained significant [RR 0.78 (95% CI 0.62, 0.98); RD -0.031(95% CI -0.003, -0.059); NNT 32 (95% CI 17, 333]. For this analysis there was no statistically significant between-study heterogeneity. A statistically significant reduction was also found for any serious infection, one or more episodes, when all studies were combined [RR 0.85 (95% CI 0.75, 0. 95); RD -0.032 (95% CI -0.010, -0.054,); NNT 31 (95% CI 19, 100). There was statistically significant between-study heterogeneity. When, in a sensitivity analysis, the high quality studies were combined the results remained statistically significant [RR 0.80 (95% CI

Cross Infection↗

PubMed2000

Glutamine supplementation for preventing morbidity in preterm infants.

BACKGROUND: The amino acid glutamine is the preferred respiratory fuel for rapidly proliferating cells under normal conditions. Recent research has suggested a number of roles for glutamine during critical illness. This research has been largely performed in experimental animals and in adults in a variety of disease settings. There is little information on the role of glutamine in children and infants, or whether glutamine supplementation is beneficial in preterm babies. OBJECTIVES: To determine the effects of glutamine supplementation on morbidity and weight gain in preterm babies. SEARCH STRATEGY: Searches were made using Medline and Embase electronic databases and specific handsearching in the English language. The search strategy followed the guidelines of the Neonatal Cochrane Review Group. SELECTION CRITERIA: Randomised controlled trials comparing glutamine supplementation to no glutamine supplementation in preterm babies at any time from birth to discharge from hospital. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including duration of parenteral nutrition, time to full enteral nutrition, rate of weight gain, rate of positive blood cultures and duration of hospital stay were extracted by both reviewers. Analysis was performed by the primary reviewer (TRJT) in accordance with the standards of the Cochrane Neonatal Review Group. MAIN RESULTS: Three trials met the selection criteria. Data on proportion of babies having one or more of positive blood cultures were available from all three studies. Meta-analysis showed no significant difference between glutamine-supplemented and non-supplemented babies; RR = 0.73 (95% CI 0.44, 1.23), RD = -8.8% (95% CI -23.2, 5.5). Data for other outcome variables were pooled from two studies. There were no significant differences between glutamine-supplemented and non-supplemented babies for days to full enteral nutrition (WMD 0.42, 95% CI -3.0, 3.8), rate of weight gain (WMD 0.6 g/kg/d, 95% CI -1.6, 2.8) or days of hospital stay (WMD -2.4, 95% CI -14.9, 10.2). REVIEWER'S CONCLUSIONS: There is no evidence to support the routine use of parenteral or enteral glutamine supplementation in preterm babies. A large randomised controlled trial should be performed to determine whether or not glutamine supplementation enhances gut integrity and reduces sepsis rate.

Dietary Supplements↗

PubMed1993

Maternal placental vasculopathy and infection: two distinct subgroups among patients with preterm labor and preterm ruptured membranes.

OBJECTIVE: Our aim was to find out whether patients delivered preterm because of preterm labor or preterm premature rupture of membranes can be categorized according to clinical characteristics and placental pathologic findings. STUDY DESIGN: We performed a case-control study of 105 patients who were delivered preterm, 42 because of preterm labor and 63 because of premature rupture of membranes, and 105 patients who were delivered at term after uncomplicated pregnancies. RESULTS: Maternal placental vascular lesions were present in 14 (34.1%) patients with preterm labor, 19 (35.1%) patients with premature rupture of membranes, and 9 (11.8%) control patients (odds ratios 3.8 and 4.0, 95% confidence intervals 1.3 to 11.1 and 1.5 to 10.8, p = 0.0065 and 0.0022, respectively). Infection of the products of conception was found in 16 patients (38%) with preterm labor, 23 patients (36.5%) with premature rupture of membranes, and 19 control patients (18%) (odds ratios 2.7 and 2.6, 95% confidence intervals 1.1 to 6.6 and 1.2 to 5.6, p = 0.017 and 0.01, respectively). Patients with maternal placental vasculopathy had significantly different characteristics compared with those of infected patients. CONCLUSIONS: It is possible to identify two subgroups of patients among those who are delivered preterm because of preterm labor or premature rupture of membranes, one with infection of the products of conception and another with maternal placental vasculopathy.

Case-Control Studies↗

PubMed2000

The preterm prediction study: quantitative fetal fibronectin values and the prediction of spontaneous preterm birth. The National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

OBJECTIVE: A cervicovaginal fetal fibronectin value of >/=50 ng/mL has been used to define women at risk of having a preterm birth. We evaluated the relationship between quantitative fetal fibronectin values and spontaneous preterm birth. STUDY DESIGN: Cervical and vaginal specimens for fetal fibronectin were obtained at 24, 26, 28, and 30 weeks' gestation from 2926 women. Quantitative fetal fibronectin values were calculated by using absorbances determined by enzyme-linked immunosorbent assay. The highest fetal fibronectin value (cervical or vaginal) for each woman at each visit was evaluated in relation to spontaneous preterm birth at <35 weeks' gestation. Receiver operating characteristic curves were constructed to determine the optimal cutoff point for fetal fibronectin values to predict spontaneous preterm birth at <35 weeks' gestation and within 4 weeks of testing. RESULTS: The risk of spontaneous preterm birth increased as a function of increasing fetal fibronectin values from approximately 20 to 300 ng/mL. Fetal fibronectin values > or =300 ng/mL were not associated with a further increase in spontaneous preterm birth. Examination of the receiver operating characteristic curve indicates that the optimal cutoff point for a positive fetal fibronectin test result at 24 to 30 weeks' gestation to predict spontaneous preterm birth at <35 weeks is between 45 and 60 ng/mL. CONCLUSION: Increasing levels of cervicovaginal fetal fibronectin up to 300 ng/mL are associated with an increasing risk of spontaneous preterm birth. Nevertheless, at 24 to 30 weeks, the value currently used, 50 ng of fetal fibronectin per milliliter, appears to be a reasonable cutoff point for predicting spontaneous preterm birth at <35 weeks' gestation.

Cervix Uteri↗

PubMed2002

Activation of coagulation system in preterm labor and preterm premature rupture of membranes.

OBJECTIVE: Thrombin, originally discovered as a coagulation factor, is a multifunctional protease capable of inducing myometrial contractions in vitro and in vivo. This enzyme has been implicated in the mechanisms of premature labor. Plasma concentrations of thrombin-antithrombin (TAT) complexes are an index of in vivo thrombin generation. The purpose of this study was to determine whether patients with premature labor and preterm premature rupture of membranes (PROM) have evidence of increased thrombin generation in maternal blood, as determined by the TAT complex concentrations. METHODS: A cross-sectional study was designed to determine plasma concentrations of TAT complexes in 110 women in the following groups: non-pregnant women (n = 20); normal pregnant women (n = 30); women in preterm labor with intact membranes (n = 30); and women with preterm PROM (n = 30). TAT complex concentrations were determined with a sensitive and specific immunoassay. Statistical analysis was conducted with non-parametric statistics. RESULTS: Patients with preterm labor and intact membranes had a significantly higher median plasma TAT complex concentration than normal pregnant women (women in preterm labor, median 19.1 microg/l; range 7.4-406 vs. normal pregnant women, median 15 microg/l; range 6.8-32.5; p = 0.03). Patients with preterm PROM had a higher median TAT complex concentration than normal pregnant women (preterm PROM, median 19.1 microg/l; range 4.7-738.6 vs. normal pregnant women, median 15 microg/l; range 6.8-32.5; p = 0.03). Normal pregnancy was associated with a higher median plasma TAT complex concentration than the non-pregnant state (normal pregnant women, median 15 microg/l; range 6.8-32.5 vs. non-pregnant women, median 2.7 microg/l; range 0.9-14.2; p < 0.001). CONCLUSION: Preterm labor and preterm PROM are associated with an excess generation of thrombin.

Adolescent↗

PubMed1991

Vaginal Bacteroides species are associated with an increased rate of preterm delivery among women in preterm labor.

The relationship of high concentrations of vaginal microorganisms with an increased rate of preterm delivery (less than or equal to 34 weeks) among women in preterm labor was evaluated. Quantitative vaginal cultures were obtained from 211 women in preterm labor between gestational ages of 22 and 34 completed weeks. Preterm delivery occurred in 139 (66%). The rate of preterm delivery was determined by Cox proportional hazards models. Women with greater than 10(7) cfu/ml of vaginal fluid of facultative lactobacilli had a 40% decreased rate of preterm delivery (rate ratio [RR] = 0.6, 95% confidence interval (CI) = 0.4-0.9). An increased rate of preterm delivery occurred among women with Bacteroides bivius at concentrations of greater than 10(4) cfu/ml (RR = 2.0, 95% CI = 1.4-2.9) and Bacteroides fragilis (RR = 1.7, 95% CI = 1.0-2.8). Other microorganisms, including Gardernella vaginalis, the genital mycoplasmas, group B streptococci, Escherichia coli, and Peptostreptococcus species, were not associated with an increased rate of preterm delivery for women in preterm labor.

Adolescent↗

PubMed1994

Metabolic balance studies and plasma amino acid concentrations in preterm infants fed experimental protein hydrolysate preterm formulas.

The aim of this study was to investigate absorption and retention of nitrogen, fat, calcium, phosphorus and magnesium, as well as plasma amino acid concentrations in 19 preterm infants fed three experimental protein hydrolysate preterm formulas (PTHF): seven received a preterm formula based on 100% whey hydrolysate protein (PTHF1), seven other infants were fed a preterm formula based on a mixture of 78% whey and 22% casein hydrolysed protein (PTHF2) and a third group of five infants were fed the same type of protein hydrolysate (78/22) enriched with histidine (PTHF3). Metabolic balances (n = 39) and plasma amino acid concentrations (n = 12) in preterm infants fed a standard preterm formula (whey/casein: 60/40) were included as a control group. Amino acid composition of the formulas was determined after complete hydrolysis with 12 N HCl. Compared with the standard preterm formula, the use of protein hydrolysate formulas led to a decrease in nitrogen and phosphorus absorption without modification of retention. Net absorption of calcium and magnesium was not significantly different in the four groups but calcium intake necessary to obtain calcium retention similar to the standard preterm formula was higher in the infants fed the hydrolysate formulas. Plasma amino acid concentrations were related to the amino acid composition of the formulas. Compared with the standard preterm formula, all three protein hydrolysate formulas led to a significant increase in plasma threonine, and a decrease in tyrosine and phenylalanine concentrations. In addition, there was an important reduction in plasma histidine concentrations with PTHF1.(ABSTRACT TRUNCATED AT 250 WORDS)

Amino Acids↗

PubMed2004

Maternal plasma procalcitonin concentrations in patients with preterm labor and intact membranes--prediction of preterm delivery and admission-to-delivery interval.

The purpose of this study was to evaluate procalcitonin (PCT) plasma levels in pregnancy complicated by preterm labor and to determine their value in the prediction of preterm delivery and the length of the admission-to-delivery interval. The study population consisted of 53 patients with preterm labor and 31 healthy pregnants. The study patients were divided according to the delivery time and to the admission-to-delivery interval. Plasma PCT concentrations were higher in preterm labor than in healthy pregnants. Although at the onset of preterm labor plasma PCT concentrations in patients who delivered prematurely were higher than in patients who, after tocolytic treatment, delivered at term, the difference was not significant. Also in cases of preterm labor delivered within and after three and seven days of admission no differences were observed. The highest values in the prediction of preterm delivery and the length of admission-to-delivery interval corresponded to a PCT concentration of 1.7 ng/ml. These findings suggest that although preterm labor is associated with increased PCT concentrations in maternal plasma, there is no significant association either between plasma concentration of PCT at the moment of threat and preterm delivery, or the admission-to-delivery interval. The predictive value of plasma PCT determinations is unsatisfactory.

Adult↗

PubMed2000

Doxapram treatment for apnea in preterm infants.

BACKGROUND: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia which may be severe enough to require resuscitation including use of positive pressure ventilation. Doxapram has been used to stimulate breathing and so prevent apnea and its consequences. OBJECTIVES: In preterm infants with recurrent apnea, does treatment with doxapram lead to a clinically important reduction in apnea and use of Intermittent positive airways pressure (IPPV), without clinically important side effects? SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal trials, the Cochrane Collaboration Clinical Trials Register, MEDLINE (using text words 'doxapram', 'apnea or apnoea' and Mesh term 'infant, premature') previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, mainly in the English language. Also an expert informant's search in the Japanese language was made by Prof. Y. Ogawa in 1996. SELECTION CRITERIA: All trials utilising random or quasi-random patient allocation, in which doxapram was used for the treatment of apnea in preterm infants were included. DATA COLLECTION AND ANALYSIS: Each author evaluated the papers for quality and inclusion criteria. Independent data extraction was carried out. MAIN RESULTS: Only one trial, which randomized 11 infants to intravenous doxapram and 10 infants to placebo, was found. There were fewer treatment failures after 48 hours in the group of preterm infants treated with doxapram (4/11) compared with the group treated with placebo (8/10). The wide confidence intervals made this result non-significant [RR 0.45 (0.20, 1.05)]. Only one infant, who was from the placebo group, was given IPPV. Of the seven responders by 48 hours in the group of 11 who received doxapram, five failed to respond between 48 hours and seven days after commencement of therapy. This gives a late failure rate of 9/11, similar to the short term failure rate in the placebo group of 8/10. It is not possible to evaluate the late responses of all those in the placebo group since they crossed over to a treatment arm. REVIEWER'S CONCLUSIONS: Although intravenous doxapram might reduce apnea within the first 48 hours of treatment, there are insufficient data to evaluate the precision of this result or to assess potential adverse effects. No longterm outcomes have been measured. Further studies are needed to determine the role of this treatment in clinical practice.

Apnea↗

PubMed2000

Methylxanthine treatment for apnea in preterm infants.

BACKGROUND: Recurrent apnea is common in preterm infants, particularly at very early gestational ages. These episodes of loss of effective breathing can lead to hypoxemia and bradycardia which may be severe enough to require resuscitation including use of positive pressure ventilation. Methylxanthines have been used to stimulate breathing and prevent apnea and its consequences. OBJECTIVES: The objective of this review is to determine if methylxanthine treatment in preterm infants with recurrent apnea leads to a clinically important reduction in apnea and use of intermittent positive pressure ventilation (IPPV), without clinically important side effects. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts of conferences and symposia proceedings, expert informants, journal handsearching mainly in the English language. SELECTION CRITERIA: All trials utilising random or quasi-random patient allocation, in which methylxanthine (theophylline or caffeine) was compared with placebo or no treatment for apnea in preterm infants, were included. DATA COLLECTION AND ANALYSIS: Methodological quality was assessed independently by the two authors. Data were extracted independently by the two authors. Treatment effects were expressed as relative risk (RR) and risk difference (RD) and their 95% confidence intervals, using a fixed effect model. For significant results, the inverse of the risk difference (1/RD) was used to calculate the number needed to treat (NNT). MAIN RESULTS: The results of four trials which enrolled a total of 110 preterm infants with apnea indicate that methylxanthine therapy leads to a reduction in apnea and use of IPPV in the first 2 - 7 days. There are insufficient data to evaluate side effects and no data to examine effects within different gestational age groups. There are no trial data which examine long term effects. REVIEWER'S CONCLUSIONS: Methylxanthines are effective in reducing the number of apneic attacks and the use of mechanical ventilation in the two to seven days after starting treatment. In view of its lower toxicity, caffeine would be the preferred drug. Although the safety of methylxanthine therapy has been suggested in cohort studies, there are no trial data on longterm outcome. In order to indicate which infants are likely to benefit from treatment, there is a need for stratification by gestation and/or other risk factors in future studies. In any future studies the longer term effects of treatment on growth and development should be evaluated.

Apnea↗

PubMed2000

Magnesium for preventing preterm birth after threatened preterm labour.

BACKGROUND: Magnesium therapy is sometimes continued after an episode of threatened preterm labour in an attempt to prevent the onset of further preterm contractions. OBJECTIVES: The objective of this review was to assess the effects of magnesium maintenance therapy on preventing preterm birth after threatened preterm labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register. SELECTION CRITERIA: Randomised controlled trials of magnesium therapy given to women after threatened preterm labour. DATA COLLECTION AND ANALYSIS: Trial quality assessment and data extraction were done independently by two reviewers. MAIN RESULTS: Two trials were included. Both were of poor quality and neither study included any long-term follow up of infants. The incidence of preterm birth or perinatal mortality was not reduced by magnesium maintenance therapy compared to alternative therapy or no treatment. REVIEWER'S CONCLUSIONS: There is not enough evidence to show that magnesium maintenance therapy is effective in preventing preterm birth after an episode of threatened preterm labour.

Female↗

PubMed2002

Magnesium sulphate for preventing preterm birth in threatened preterm labour.

BACKGROUND: Magnesium sulphate is used to inhibit uterine activity in women in preterm labour to prevent preterm birth. OBJECTIVES: To assess the effectiveness and safety of magnesium sulphate therapy given to women in threatened preterm labour with the aim of preventing preterm birth and its sequelae. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (May 2002) and the Cochrane Controlled Trials Register (The Cochrane Library, Issue 2, 2002). SELECTION CRITERIA TYPES OF PARTICIPANTS: Women thought to be in preterm labour. Types of interventions: Magnesium sulphate as the only tocolytic, administered intravenously or orally, compared with either placebo, no treatment or alternative tocolytic therapy. Types of outcome measures: Measures of effectiveness, complications, women's satisfaction with their care and health service use. DATA COLLECTION AND ANALYSIS: Assessments of trial eligibility, quality and data extractions were done by at least two of the reviewers. MAIN RESULTS: Over 2000 women were recruited into the 23 included trials. Only nine trials were rated of high quality for the concealment of allocation. In the magnesium sulphate versus control (all studies) no difference was seen for the risk of birth within 48 hours of treatment for women given magnesium sulphate compared with controls when using a random effects model (relative risk (RR) 0.85, 95% confidence interval (CI) 0.58-1.25, 11 trials, 881 women). No benefit was seen for magnesium sulphate on the risk of giving birth preterm (<37 weeks) or very preterm (<34 weeks). The risk of death (fetal and paediatric) was higher for infants exposed to magnesium sulphate (RR 2.82, 95% CI 1.20-6.62, 7 trials, 727 infants). There were only two fetal deaths, both in the magnesium sulphate group in one study. The six other trials reported there were no fetal deaths. No differences for total paediatric mortality were shown in the six trials with data. No beneficial effect was seen from using magnesium sulphate on the risk of other neonatal morbidity. A non-significant reduction in the risk of cerebral palsy was reported at follow up at 18 months corrected age (RR 0.14, 95% CI 0.01-2.60, 1 trial, 99 children). REVIEWER'S CONCLUSIONS: Magnesium sulphate is ineffective at delaying birth or preventing preterm birth, and its use is associated with an increased mortality for the infant. Any further trials should be of high quality, large enough to assess serious morbidity and mortality, compare different dose regimens, and provide neurodevelopmental status of the child.

Female↗

PubMed2000

Thyroid hormone for preventing of neurodevelopmental impairment in preterm infants.

BACKGROUND: Observational studies have shown an association between transiently low thyroid hormone levels in preterm infants in the first weeks of life (transient hypothyroxemia) and an abnormal neurodevelopmental outcome. Thyroid hormone therapy might prevent this morbidity. OBJECTIVES: To assess whether thyroid hormone therapy in preterm infants without congenital hypothyroidism results in clinically important changes in neonatal and long term outcomes in terms of both benefits and harms. SEARCH STRATEGY: The standard search strategy of the Neonatal Review Group was used. This included searches of the Oxford Database of Perinatal Trials, Cochrane Controlled Trials Register, MEDLINE, previous reviews including cross references, abstracts, conferences, symposia proceedings, expert informants and journal handsearching in the English language. SELECTION CRITERIA: All trials using random or quasi-random patient allocation, in which thyroid hormone therapy (either treatment or prophylaxis) was compared to a control in premature infants. DATA COLLECTION AND ANALYSIS: Primary clinical outcomes included measures of neurodevelopmental outcome and mortality. Assessment of trial quality, data extraction and synthesis of data, using relative risk (RR) and weighted mean difference (WMD), were performed using standard methods of the Cochrane Collaboration and its Neonatal Review Group. MAIN RESULTS: Eight studies were identified that compared thyroid hormone treatment to control. Four randomized or quasi-randomized studies met inclusion criteria (Chowdhry 1984, Amato 1989, van Wassenaer 1997 and Vanhole 1997). All studies enrolled preterm infants < 32 weeks gestation, but used different timing, dose and duration of treatment with thyroid hormones. Three studies used thyroxine, whereas Amato 1989 used triiodothyronine. Only two studies with neurodevelopmental follow-up were of good methodology (van Wassenaer 1997 and Vanhole 1997). All studies were of small size with the largest, van Wassenaer 1997, enrolling 200 infants. A lack of comparability of data (neurodevelopmental test or timing of follow-up) prevented meta-analytic pooling of the studies for neurodevelopmental outcomes. There was no significant difference in mortality to discharge (typical relative risk 0.74, 95% CI 0.44, 1.26) in infants who received thyroid hormone treatment compared to controls. In individual studies, no significant differences were found in neurodevelopmental outcomes including risk of abnormal neurological outcome, and Bayley Mental or Psychomotor Development Indices. No data were available for the incidences of cerebral palsy or sensorineural impairment. Fraction of inspired oxygen was lower in infants receiving triiodothyronine in one small quasi-randomized study (Amato 1989), but not in infants receiving thyroxine in a randomized study (Vanhole 1997). No other differences were found to suggest a reduced severity of respiratory distress syndrome in infants receiving early thyroid hormone therapy. REVIEWER'S CONCLUSIONS: This review does not support the use of thyroid hormones in preterm infants to reduce neonatal mortality, improve neurodevelopmental outcome or to reduce the severity of respiratory distress syndrome. The a posteriori subgroup analyses of data from one study (van Wassenaer 1997) which showed benefits in infants 24-25 weeks gestation should be treated with caution. The small number of infants included in trials incorporated in this review limits the power of the meta-analysis to detect clinically important differences in neonatal outcomes. Future trials should be of sufficient size to detect clinically important differences in neurodevelopmental outcomes. They should consider enrolling those infants most likely to benefit from thyroid hormone treatment such as infants born at less than 27 weeks gestation and use thyroid hormones as treatment instead of prophylaxis.

Developmental Disabilities↗

PubMed2000

Diuretics for respiratory distress syndrome in preterm infants.

BACKGROUND: Lung edema may complicate respiratory distress syndrome (RDS) in preterm infants. OBJECTIVES: The aim of this review was to assess the risks and benefits of diuretic administration in preterm infants with RDS. SEARCH STRATEGY: We used the standard search method of the Cochrane Neonatal Review Group. We searched Medline, Embase and the Cochrane Controlled Trials Register from the Cochrane Library, using the following keywords: and . In addition, we searched the abstract books of the American Thoracic Society and Pediatric Research Societies. SELECTION CRITERIA: We only included trials in which preterm infants with RDS and less than 5 days of age were randomly allocated to diuretic administration. Of those trials, we only included studies in which at least one of the following outcomes measures was evaluated: mortality, patent ductus arteriosus, hypovolemic shock, intraventricular hemorrhage, renal failure, duration of oxygen supplementation, duration of mechanical ventilation, need for oxygen supplementation at 28 days of life, oxygen supplementation at 36 weeks of postconceptional age (gestational age + postnatal age), length of stay, number of rehospitalizations during the first year of life, and neurodevelopmental outcome. DATA COLLECTION AND ANALYSIS: We used the standard method for the Cochrane Collaboration which is described in the Cochrane Collaboration Handbook. Two investigators extracted, assessed and coded separately all data for each study. Any disagreement was resolved by discussion. MAIN RESULTS: Six studies met inclusion criteria. Studies available for this systematic review were all done before the current era of prenatal steroids, surfactant, indomethacin and fluid restriction. Furosemide administration had no long-term benefits. Furosemide-induced transient improvement in pulmonary function did not outweigh an increased risk for patent ductus arteriosus and for hemodynamic instability. REVIEWER'S CONCLUSIONS: There are no current data to support routine diuretic administration in preterm infants with RDS. Elective administration of furosemide or any diuretic to any patient with RDS should be carefully weighed against the risk of precipitating hypovolemia. In addition, elective administration of furosemide should be weighed against the risk of developing a symptomatic patent ductus arteriosus.

Diuretics↗

PubMed2004

Maintenance therapy with calcium channel blockers for preventing preterm birth after threatened preterm labour.

BACKGROUND: Calcium channel blocker maintenance therapy is one of the types of tocolytic therapy used after an episode of threatened preterm labour (and usually an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions. OBJECTIVES: To assess the effects of calcium channel blockers as maintenance therapy on preventing preterm birth after threatened preterm labour. SEARCH STRATEGY: We searched the Cochrane Pregnancy and Childbirth Group trials register (31 March 2004); MEDLINE (1966 to March 2004) and DARE (June 2003). SELECTION CRITERIA: Randomised controlled trials of calcium channel blockers used as maintenance therapy to prevent preterm birth after threatened preterm labour, compared with alternative drug therapy, placebo or no treatment. DATA COLLECTION AND ANALYSIS: Two reviewers independently applied the selection criteria, extracted data from the included study and assessed study quality. MAIN RESULTS: One trial of 74 women was included. No difference in the incidence of preterm birth was found when calcium channel blocker (nifedipine) maintenance therapy was compared with no treatment. Twenty-five women out of 37 in each group gave birth before 37 weeks (relative risk 1.00, 95% confidence interval 0.73 to 1.37). The trial did not report stillbirths and neonatal deaths prior to discharge. Neurological follow up of the infants was not addressed. REVIEWERS' CONCLUSIONS: The role of maintenance therapy with calcium channel blockers for preventing preterm birth is not clear. Well designed randomised trials of sufficient size with relevant outcomes are required.

Calcium Channel Blockers↗

PubMed1990

Symptoms that precede preterm labor and preterm premature rupture of the membranes.

Great emphasis has been placed on recognition of the early warning symptoms of preterm labor by both pregnant women and health care providers. In addition to the expected increase in both painless and painful uterine contractions, several symptoms have been commonly cited in textbooks and patient educational materials as preceding preterm labor including menstrual-like cramps, backache, pelvic pressure, and an increased amount of vaginal discharge. We interviewed 107 women with preterm labor, 102 women with preterm prematurely ruptured membranes, and 106 ambulatory normal pregnant women to ascertain the frequency of each of eight putative warning symptoms of preterm labor in each group. Preterm labor patients were distinguished as expected from both normal women and amniorrhexis patients by a greater frequency of painful and painless contractions. Menstrual cramps, backache, and increased vaginal discharge, symptoms often said to be normally present in pregnancy, were also significantly more common in preterm labor patients than in women with preterm membrane rupture and in normal subjects.

Adolescent↗

PubMed1993

Multicenter randomized, controlled trial of a preterm birth prevention program. Collaborative Group on Preterm Birth Prevention.

OBJECTIVE: The results of a randomized, controlled trial of a preterm birth prevention program at five centers with primarily low-income populations are presented. STUDY DESIGN: Pregnant women at high risk for preterm labor were independently randomized into intervention and control groups at each of five centers (2395 women). Specially trained staff instructed women in the intervention group to recognize early signs of preterm labor and to notify the staff should any sign of preterm labor occur, and women came in weekly for pelvic examinations after 20 to 24 weeks' gestation. Because the intervention had very different and contrary effects on preterm birth rates across these sites, the analysis focused on patient risks and on measures of the process of care as possible explanations for the differences in outcomes. RESULTS: The observed spontaneous preterm birth rates, when averaged for all sites, were not lower in the intervention group than in the control groups (16.1% vs 15.4% for < 37 completed weeks' gestation, 11.9% vs 10.9% for < 36 completed weeks). There was substantial heterogeneity of program effects between centers (p < 0.01 for homogeneity test statistic). The differences in intervention effects between centers were explainable only in part by patient risk characteristics (p < 0.10 for homogeneity test statistic). The only intermediate measure of the process of care that tended to differentiate among sites with positive intervention effects was the rate of hospital admission for preterm labor. Sites with elevated admission rates in the intervention group versus the control group tended to have negative intervention effects on outcomes. CONCLUSION: Because the preterm birth prevention program did not show a reliable benefit and because the reasons for varied outcomes are not understood, the use of the program cannot be recommended for predominantly low-income populations.

Female↗

PubMed2005

The value of cervical length and plasma proMMP-9 levels for the prediction of preterm delivery in pregnant women presenting with threatened preterm labor.

OBJECTIVE: To assess the value of plasma proMMP-9 levels in predicting the progress of threatened preterm labor to true preterm labor and delivery within 7 days of presentation, along with the ultrasonographic measurement of cervical length. STUDY DESIGN: The study included sixty two pregnant women presented in the 2nd Department of Obstetrics and Gynecology of University of Athens at Aretaieion Hospital with threatened preterm labor. On subjects' presentation, cervical length was evaluated with transvaginal ultrasonography, plasma proMMP-9 levels were measured with the use of a solid phase enzyme immunoassay, and maternal characteristics (smoking, history of preterm delivery and parity) as well as the use of tocolytics were recorded. Subjects were followed up for premature delivery within 7 days. ROC analysis for plasma proMMP-9 levels was performed and logistic regression analysis was used for the evaluation of the prognostic effect of the parameters. RESULTS: The only significant predictors for establishment of true preterm labor and delivery within 7 days of presentation were cervical length (with cutoff value 15 mm: odds ratio=0.022, 95% CI=0.002-0.243, p=0.002) and plasma proMMP-9 (with cutoff value 67.15 ng/ml: odds ratio=0.035, 95% CI=0.003-0.388, p=0.006). The combination of the adopted proMMP-9 and cervical length cutoff values was characterized by a sensitivity of 90.9% and a specificity of 98.3% for predicting the progress to true preterm labor and delivery. CONCLUSION: Plasma proMMP-9 levels could possibly serve as a predictive factor for the progress of threatened preterm labor to true preterm labor and delivery within 7 days of presentation, along with the ultrasonographic evaluation of cervical length.

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