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PubMed2000

Involution of retinopathy of prematurity. Cryotherapy for Retinopathy of Prematurity Cooperative Group.

OBJECTIVE: To report the timing of involution of acute retinopathy of prematurity (ROP). DESIGN: An analysis of prospective retinal observational data recorded at infants' eye examinations. PARTICIPANTS: Infants from the Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) had birth weights less than 1251 g and served as subjects. The study population included 766 children who were examined in 5 of the 23 study centers and who developed at least 1 clock hour of acute ROP, stages 1 through 3. One eye from each patient was randomly chosen for analysis. MAIN OUTCOME MEASURES: Investigators documented the location, extent, and severity of ROP during serial retinal examinations. The onset of the ROP's involution was determined from a review of these data, applying a set of predetermined criteria. RESULTS: Acute-phase ROP began to involute at a mean of 38.6 weeks postmenstrual age. In 90% of patients, the ROP began to involute before 44 weeks of postmenstrual age. Acute ROP that demonstrated involution by moving from zone II to zone III was associated with an unfavorable outcome in 2 (1%) of 200 cases. Retinopathy of prematurity that was present only in zone III during a child's serial retinal examinations was never associated with the development of a partial or total retinal detachment. CONCLUSIONS: The onset of involution of acute retinopathy of prematurity correlates better with postmenstrual rather than with chronological age. This is reminiscent of the reported similar correlation of postmenstrual age to the time of onset of prethreshold and threshold ROP. Zone III ROP was nearly always associated with a favorable outcome.

Acute Disease↗

PubMed2000

Elective high frequency oscillatory ventilation versus conventional ventilation for acute pulmonary dysfunction in preterm infants.

BACKGROUND: Respiratory failure due to lung immaturity is a major cause of mortality in preterm infants. Although intermittent positive pressure ventilation (IPPV) saves lives, lung distortion during its use is associated with lung injury and chronic lung disease (CLD). Conventional IPPV is provided at 30-80 breaths per minute while a newer form of ventilation called high frequency oscillatory ventilation (HFOV) provides 'breaths' at 10-15 seconds. This has been shown to result in less lung injury in experimental studies. OBJECTIVES: The objective of this review is to determine whether the elective use of high frequency oscillatory ventilation (HFOV) as compared to conventional ventilation in preterm infants who are mechanically ventilated for the respiratory distress syndrome decreases the incidence of chronic lung disease (CLD) without adverse effects. SEARCH STRATEGY: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts, conferences and symposia proceedings, expert informants, journal handsearching by the Cochrane Collaboration, mainly in the English language. Expert informant's search in the Japanese language was made by Prof. Y. Ogawa. SELECTION CRITERIA: Randomized controlled trials comparing HFOV and CV in preterm or low birth weight infants with pulmonary dysfunction, mainly due to RDS, who are to be given IPPV. Randomization and commencement of treatment should have been as soon as possible after the start of IPPV and usually in the first 12 hours of life. DATA COLLECTION AND ANALYSIS: The methodological quality of each trial was independently reviewed by the various authors. Each author extracted data separately; they were compared and differences were resolved. The standard method of the Cochrane Neonatal Review Group was used to synthesize the data using relative risk (RR) and risk difference (RD). From 1/RD the number needed to treat (NNT) for benefits, and number needed to harm (NNH) for adverse effects, were calculated. MAIN RESULTS: Meta-analysis of the six eligible studies comparing HFOV with CV revealed that there is no difference in mortality. There are trends toward decreases in CLD in survivors at 28-30 days, 'death or CLD at 28-30 days' and CLD in survivors at 36-37 weeks postmenstrual age or discharge in the HFOV group. However, there are trends towards increases in severe (grades 3 & 4) intraventricular hemorrhage (IVH) and in periventricular leukomalacia (PVL) in the HFOV group. HFOV results in a small increase in any air leak syndrome (ALS), [summary RR 1.20 (1.03, 1.39)]. Only 2 trials have included neurodevelopmental follow up and more survivors in the HFOV group are abnormal [summary RR 1.26 (1.01, 1.58)]. In the subgroup of four trials where a high volume strategy (HVS) was used, HFOV results in more favourable pulmonary outcomes. There are significantly lower rates of CLD in survivors at 28-30 days [summary RR 0.53 (0.36, 0.76)] and of 'death or CLD at 28-30 days' [summary RR 0.56 (0.40, 0.77) with a non-significant trend towards a reduction in oxygen use at 36-37 weeks postmenstrual age or discharge [summary RR 0.74 (0.55, 1.01)]. There were no differences in the rates of IVH or PVL. Of the four trials in the subgroup using surfactant routinely, three also used the HVS. The trends in results were similar with surfactant to those for the HVS subgroup analysis. One trial suggests that HFOV may reduce the cost of in-hospital care. In the subgroup of two trials (HIFI 1989, Rettwitz-Volk 1998) not using a HVS there is no effect of HFOV on the rate of CLD; however, there is an increase in the rate of PVL [summary RR 1.64 (1.02, 2.64). REVIEWER'S CONCLUSIONS: The overall meta-analyses is dominated by the large HIFI study which did not use the HVS recommended on the basis of animal studies, and in which surfactant was not available. Studies which used HVS have shown some benefits in short term measures of CLD without an in

High-Frequency Ventilation↗

PubMed1996

Sonographic determination of the position of the conus medullaris in premature and term infants.

We determined the position of the conus medullaris (CM) relative to the vertebral column in premature and term babies and assessed its ascent in 99 children, using ultrasound. We related level to the middle of a vertebral body or an intervertebral space. Postmenstrual age at examination was related to the level of the CM with the Krus-kal-Wallis test. The children were divided into five age groups and the level of the CM was analysed with a chi-squared test. An increase in postmenstrual age was significantly associated with higher levels of the CM (P = 0.003). The CM ascended in the older children (P = 0.04). The CM is at the L2/L3 intervertebral space in premature babies of 27-29 weeks of postmenstrual age. In babies of more advanced gestation a statistically significant ascent of the CM is observed and the CM is at the adult level of the L1/L2 intervertebral space around the 40th postmenstrual week. No further ascent occurs thereafter.

Chi-Square Distribution↗

PubMed1994

Psychosocial factors in premenstrual dysphoria: stressors, appraisal, and coping processes.

Relationships between event content of daily stressors, appraisal of daily stressors, coping processes, and menstrual cycle phase were examined in women with premenstrual dysphoria (PMD) and controls. Seventy-eight women completed the Daily Rating Form, the Daily Coping Scale and the Multiple Affect Adjective Checklist-Revised on a daily basis during the premenstrual and postmenstrual phases. No premenstrual-postmenstrual differences in frequency of occurrence of stressors were reported. Academic and interpersonal stressors were the most frequently reported stressors during both cycle phases. PMD women appraised daily stressors as being more stressful, undesirable, and changeable premenstrually than postmenstrually as compared to controls. Catharsis was used more frequently premenstrually as compared to postmenstrually by PMD women. Premenstrually, women with PMD sought social support more frequently than controls. Interactive relationships between appraisal and coping style varied as a function of cycle phase for PMD women. A state-dependent model of menstrual-related mood changes is supported.

Adaptation, Psychological↗

PubMed2004

[Diagnosis of premenstrual disorders].

BACKGROUND AND OBJECTIVE: There is no valid method in the German literature for assessing premenstrual disorders. This study was undertaken to translate into German, validate and test the reliability of the "Premenstrual Syndrome Tension Observer/Self-Rating Scale" and the "Visual Analogue Scale for Premenstrual Disorders". PATIENTS AND METHODS: 55 patients diagnosed with premenstrual dysphoric disorder took part in the study. After fullfilling the inclusion criteria, sociodemographic and medical data were studied. The self-assessment by PMTS-SR and VAS-PmD was done two days premenstrual and nine days postmenstrual by all 55 patients. The objective assessment (done by a clinical interview and the PMTS-O as the reference standard) was obtained afterwards without knowing the self-assessment. RESULTS: The average age of the tested women was 35 years. The average increase of 85 % in premenstrual symptoms (PMTS-O and PMTS-SR scale) indicates a group with severe premenstrual disorders. The correlation coefficient between PMTS-O and PMTS-SR scale, pre- and postmenstrually, was 0.83 and 0.84, respectively (p < 0.0001 for both). The correlation coefficient between PMTS-O and VAS-PmD, pre- and postmenstrually, was 0.5 and 0.69, respectively (p < 0.0001 for both). This was calculated at 0.64 and 0.67, respectively (p < 0.0001 for both) between PMTS-SR and VAS-PmD. Reliability analysis for PMTS-O was, pre- and postmenstrually, 0.71 and 0.29, respectively, for PMTS-SR 0.77 and 0.78, respectively, and for VAS-PmD it was 0.79 and 0.87, respectively. CONCLUSIONS: The German version of the PMTS-O and the PMTS-SR scale are "application friendly" as well as proven to be a valid and reliable method for supporting the diagnosis, course of disease and research aspects concerning premenstrual disorders. Initially VAS-PmD should be used in combination with PMTS-O and PMTS-SR scale.

Adult↗

PubMed2005

[Screening for retinopathy of prematurity: results of one centre between 1991 and 2002].

PURPOSE: The aim of this study was to analyse the results of retinopathy of prematurity (ROP) screening, stage of disease and time of treatment from one tertiary care centre. PATIENTS AND METHODS: Between 1991 and 2001, 666 infants with a gestational age (GA) < 33 weeks or birth weight (BW) less than < 1501 g were examined. Coagulation treatment was performed in accordance with the Cryo-ROP study, after reaching the threshold. All infants were followed-up until a stable retinal situation was reached. RESULTS: Mean GA of the 666 infants was 28.5 +/- 2.3 weeks. Mean BW was 1180 +/- 372 g. During the years of screening, the GA and BW significantly decreased, but no significant change in the yearly incidence of ROP was detected. 460 (69.1 %) of the infants did not develop any stage of ROP. Maximum stage of ROP in the worse eye was stage one in 51 (7.6 %) infants, stage two in 59 (8.9 %) infants and stage three below threshold in 62 (9.3 %) infants. 34 (5.1 %) infants were treated with coagulation treatment. Mean time of treatment was 36.5 weeks postmenstrual age, or 10.7 weeks postnatal age. Postnatal age showed a better correlation to treatment time than postmenstrual age. No infant was treated before seven weeks of life and not before 32 weeks postmenstrual age. CONCLUSION: In spite of the increasing survival of children with lower GA and BW the incidence of ROP has not increased, and the incidence of ROP in our centre appears to be comparable to other international studies. In contrast to the Cryo-ROP study, treatment time correlates better to postnatal age than to postmenstrual age. All infants who underwent treatment were detected at an appropriate time using German screening guidelines.

Age Factors↗

PubMedDate not supplied

Skin conductance and heart rate in women with premenstrual syndrome.

This study investigated the effects of the menstrual cycle phase on certain components of autonomic arousal and task performance. Premenstrual syndrome (PMS) women and matched controls (non-PMS) were tested both premenstrually and postmenstrually. The conditions selected were a) the presentation of 10 tones, b) a proofreading performance task, and c) a word-association learning task. Skin conductance and heart rate were continuously monitored. No significant effects were found on baseline physiological measures, or on proofreading or word-association performance. A significant point in cycle effect for skin conductance and HR orienting response to the tones was found showing smaller HR and skin conductance responses postmenstrually. Several significant PMS classifications by point in menstrual cycle interactions were found. These indicated that, paradoxically, the non-PMS subjects showed higher spontaneous skin conductance responding during the word association task and higher skin conductance responses to tones prior to menses. While in contrast, PMS subjects yielded higher responding on the same measures postmenstrually. On stress ratings, PMS subjects reported experiencing more stress postmenstrually. Results are discussed in terms of the possible role of expectancy factors and inaccurate self-monitoring.

Adult↗

PubMedDate not supplied

Changes in premenstrual symptoms in women with schizophrenia: a prospective study.

OBJECTIVE: We investigated whether the psychiatric symptoms and clinical features of schizophrenia change during the premenstrual phase in female patients. METHODS: We observed 30 female schizophrenic inpatients over one menstrual cycle. All subjects met DSM-IV criteria for schizophrenia, and all had a regular menstrual cycle. All subjects completed the Daily Rating Form (DRF) every evening, and one psychiatrist rated the subjects (using the Brief Psychiatric Rating Scale [BPRS]) once during each of the three menstrual phases (premenstrual, menstrual, and postmenstrual). Serum levels of estradiol (E2) and progesterone were measured on the fifth to seventh day of both the premenstrual and postmenstrual phases. Data from the 24 subjects who completed the DRF correctly and completely were used for statistical analysis. RESULTS: The mean total BPRS score for the 24 subjects was highest in the premenstrual phase and lowest in the postmenstrual phase, and a statistically significant difference was found among the three menstrual phases. Mean subtotal BPRS scores showed statistically significant differences among the three menstrual phases in anxiety/depression and withdrawal/retardation, but not in the psychotic symptom subscales. Mean serum E2 level showed a trend of increasing from the premenstrual phase to the postmenstrual phase. However, there was no significant correlation between DeltaBPRS and DeltaE2. When the criterion of 30% change was applied, the DRF items of depressed mood, anxious/nervous/restless, hostile/aggressive, and less/impaired work showed high frequencies of change in the premenstrual phase. Somatic items of abdominal pain, breast pain, and headache showed significant change with the 30% change rule on the DRF. On both the BPRS and DRF scores, premenstrual change of affective and behavioral symptoms was prominent, whereas the change of psychotic symptoms was minimal on the BPRS. In addition, in the premenstrual phase, there was a statistically significant correlation between the total BPRS score and the mean total DRF score. There was no correlation between premenstrual change in symptoms and hormonal levels of E2, progesterone, and the estradiol/progesterone (E/P) ratio. CONCLUSIONS: The findings of this study suggest that premenstrual exacerbation of schizophrenic symptoms in female patients may not be a worsening of the schizophrenic symptoms but a concurrence of affective, behavioral, and somatic symptoms.

Adult↗

PubMed2006

The Photographic Screening for Retinopathy of Prematurity Study (Photo-ROP): study design and baseline characteristics of enrolled patients.

OBJECTIVE: The Photographic Screening for Retinopathy of Prematurity Study (Photo-ROP) sought to evaluate the utility of digital wide-angle photographic fundus screening for retinopathy of prematurity (ROP) as compared to bedside indirect ophthalmoscopy. This article describes the study design and presents baseline characteristics of the subjects. DESIGN: Prospective, multicenter, masked, Internet-based clinical trial. PARTICIPANTS: Premature infants <31 weeks postmenstrual age at birth and <1000 g birthweight. INTERVENTIONS: Examinations began at 31 weeks postmenstrual age or 4 weeks postnatal age, whichever was later. Both eyes of all infants were imaged with a panoramic fundus imaging system followed by indirect ophthalmoscopic fundus examination. Images were transmitted via Internet to the Reading Center for interpretation by masked graders. Clinical interpretations based on indirect ophthalmoscopy were recorded for comparison with the Reading Center determinations. Examinations were performed weekly for 10 weeks or until an infant was discharged from the hospital. MAIN OUTCOME MEASURE: Sensitivity, specificity, and positive and negative predictive values of Reading Center image interpretations were compared to clinical impressions based on bedside indirect ophthalmoscopy. RESULTS: Enrollment began in February 2001 and was completed in February 2002. The target number of infants was 50, and 62 were enrolled. Of those enrolled, 51 infants (102 eyes) were considered eligible, and are the subject of this article. Mean postmenstrual age (+/- SD) at time of delivery was 26.80 +/- 1.73 weeks (median = 26.86 weeks, interquartile range [IQR] = 2.43 weeks). Mean postmenstrual age at first examination (+/- SD) was 32.19 +/- 2.86 weeks (median = 31.71 weeks, IQR = 2.29 weeks). Mean birthweight (+/- SD) was 830.51 +/- 219.57 g (median = 817 g, IQR = 225 g). Female infants comprised 49.02% of the patients. Race distribution was as follows: white 45.10%, African or black 39.22%, Hispanic 3.92%, Asian 9.80%, and other races 1.96%. Mean follow-up (+/- SD) was 5.73 +/- 3.22 weeks (median = 6 weeks, IQR = 5, range = [1, 15]). CONCLUSIONS: The Photo-ROP Study Cooperative Group successfully recruited and enrolled at-risk premature infants into a longitudinal, prospective clinical trial comparing two different diagnostic approaches. Technology employed in this study is comparable to that currently available. Design issues for this trial included establishing the information technology infrastructure for an ROP study based on digital imaging, defining the study endpoints, estimating event rates, defining a standardized imaging protocol, and defining standards for interpretation of image quality and clinical findings.

Canada↗

PubMed2006

Vancomycin pharmacokinetics in preterm neonates and the prediction of adult clearance.

WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT: *Effects of size, renal function, age (postnatal age, gestational age and postmenstrual age) as predictors of vancomycin clearance in premature neonates are established, but the relative contribution of each component remains poorly quantified, largely because these variables are closely correlated. *We have quantified the covariates contributing to vancomycin clearance population parameter variability in order to establish the major covariates required for dosing predictions. Size, standardized using allometric models, was the primary covariate used in our analysis. WHAT THIS STUDY ADDS: *Size explained 49.8%, postmenstrual age 18.2% and renal function 14.1% of clearance variability. *Descriptors of the relationship between age and clearance in premature neonates vary. *The use of a variable slope sigmoidal model to describe the relationship between clearance and postmenstrual age predicted an adult clearance of 3.79 l h(-1) 70 kg(-1) (95% confidence interval 2.76, 4.98) from premature neonatal data. AIM: To identify and quantify factors describing the variability of vancomycin clearance in premature neonates. METHODS: Population pharmacokinetics were estimated (NONMEM) in 214 neonates [postmenstrual age (PMA) 30.4 weeks, range 24-34 weeks; postnatal age 11.9 days, range 1-27 days; weight 1.30 kg, range 0.42-2.6 kg] using therapeutic drug monitoring data. Covariate analysis included weight, PMA, serum creatinine, use of inotropes or ibuprofen, positive blood culture and respiratory support. A one-compartment linear disposition model with zero order input and first-order elimination was used to describe the data (604 observations). RESULTS: The population estimate for volume of distribution (V) was 39 l 70 kg(-1) (coefficient of variation 19.4%). Clearance (CL) increased from 0.897 l h(-1) 70 kg(-1) at 24 weeks PMA to 2.02 l h(-1) 70 kg(-1) by 34 weeks PMA. The between-subject variability for CL was 18.6% and the between-occasion variability was 12.2%. The use of ibuprofen reduced clearance, but this effect was attributable to reduced renal function. Overall, 82% of the variability of CL was predictable. Size explained 49.8%, PMA 18.2% and renal function 14.1%. The use of a variable slope sigmoidal model to describe the relationship between clearance and PMA predicted an adult clearance of 3.79 l h(-1) 70 kg(-1) (95% confidence interval 2.76, 4.98). CONCLUSIONS: Size, renal function and PMA are the major contributors to clearance variability in premature neonates. The small (18%) unexplained variability in clearance suggests target concentration intervention is unnecessary if size, age and renal function are used to predict the dose. Extrapolation to an adult clearance from neonatal data is possible using allometric size models and a function describing clearance maturation.

Adult↗

PubMedDate not supplied

Home oxygen therapy after preterm birth in Western Australia.

OBJECTIVES: To review our management of infants discharged home receiving supplemental oxygen. Stable preterm infants receive low flow O(2) by nasal cannulae aiming for SaO(2) of > or = 95%. Oxygen-dependent infants must pass an air test (ability to maintain SaO(2) > 80% during 4 h disconnection from oxygen) before discharge home with supplemental oxygen. A sleep study is performed before nocturnal O(2) is ceased. METHODS: Infants less than 33 weeks gestational age (GA) who were admitted January 1999-June 2001 and discharged home with supplemental oxygen were identified through the databases and medical records of the King Edward Memorial/Princess Margaret Hospitals. The data collected were compared with an audit performed a decade earlier. RESULTS: Ninety-three infants were discharged home with supplemental oxygen between 1999 and 2001 (10% neonatal intensive care unit admissions less than 33 weeks GA; median GA 26 weeks (interquartile range 25-28). All infants had an air test before discharge: 63% failed the first air test and 30% at least two air tests. The median delay between the first air test and discharge was 2 weeks. The median postmenstrual age at discharge was 40 weeks gestation (interquartile range 38-41). Ninety infants had a sleep study before nocturnal oxygen was ceased and nine failed the first sleep study. Hospital readmission rate was 60%. More preterm infants (less than 33 weeks) were discharged with supplemental oxygen in 1999-2001 (10%, n = 96 in 1999-2001) than in 1987-1992 (2.5%, n = 53) and this was associated with an earlier discharge (40 vs 44 weeks postmenstrual age), lower oxygen requirements at discharge (60 vs 125 mL/min), earlier discontinuation of daytime and nocturnal oxygen (1 vs 4 months postmenstrual age and 2.5 vs 6 months postmenstrual age) and no increase in readmission rate (64% vs 60%). The incidence of bronchopulmonary dysplasia for these infants has remained stable at 20%. CONCLUSION: Our home oxygen programme, based on an air test predischarge and a sleep study prediscontinuation of nocturnal oxygen, facilitates early discharge home. Our data suggest that over the last decade, bronchopulmonary dysplasia is associated with less impairment in lung function. Further evidence from randomized clinical trials is required to determine optimal target range for oxygen saturation in preterm infants.

Female↗

PubMed1997

Maturation of hepatosomal mono-oxygenation and glucuronidation activities in pre- and full-term infants as studied using the [15N]methacetin urine test.

The non-distressing [15N]methacetin liver function test was modified and applied to newborn healthy infants in order to measure both the total [15N]methacetin metabolites excreted in the urine (total elimination capacity) and the proportion of glucuronated metabolite. By studying pre- and full-term normotrophic neonates 3-168 days old, the age-dependent maturation of the two developing liver function processes can be compared on the basis of either postnatal or postmenstrual age. When solely considering postnatal age, no significant differences between the pre- and full-term infants were observed in the development of the total elimination capacity. However, when postmenstrual age was considered, it became apparent that this development starts earlier in pre-term infants and continues at the same rate as their full-term counterparts, up to the postmenstrual age of approximately 280 days. This increase subsequently diminishes in the pre-terms. In the same study group, the proportion of glucuronidation, another indicator of the hepatic detoxification system, appears to develop at a lower rate in pre-term than in full-term infants. When postmenstrual age is taken into consideration, glucuronidation development is also observed to begin earlier in pre-term infants and the slower maturation is more pronounced. Although these results are not generally applicable, they contribute to a better interpretation of the [15N]methacetin liver function test--for instance when estimating effects due to environmental exposure or accurately calculating age-related drug dosage for neonates.

Acetamides↗

PubMed1998

Deformation of the palate in preterm infants.

AIM: To investigate the effect of gestation, postmenstrual age, and orotracheal intubation on palate morphology. METHODS: A prospective study was made of 76 newborn infants of 25 to 41 weeks' gestation. Palate dimensions were measured on plaster models produced from serial palatal impressions. Palate size relative to that of the mouth was assessed using a ratio of palate depth to palate width (Palatal Index). RESULTS: Palate depth and width were related to postmenstrual age and gestation. Palatal Index ranged from 0.15 to 0.57, indicating a wide variation in palate shape, but gestation and postmenstrual age had no effect. Prolonged intubation had a small effect, equivalent to an increase in palatal depth of less than 2 mm at 32 weeks' postmenstrual age. The effect was transient. CONCLUSION: Prolonged orotracheal intubation (> 10 days) leads to a small and temporary increase in palatal depth. However, this is unlikely to account for palatal grooving, which is probably caused by an overgrowth of the lateral palatine ridges.

Anthropometry↗

PubMed2004

Continuous or intermittent dosing with sertraline for patients with severe premenstrual syndrome or premenstrual dysphoric disorder.

OBJECTIVE: The authors compared the efficacy and acceptability of continuous versus intermittent treatment with a selective serotonin reuptake inhibitor in women with severe premenstrual syndrome and determined the effects of postmenstrual symptom severity and depression history as covariates of the treatment response. METHOD: Patients who met symptom criteria and reported impaired functioning after three screening cycles were randomly assigned to three cycles of double-blind, placebo-controlled treatment with continuous (full-cycle dosing) or intermittent (luteal-phase dosing) sertraline. The design was stratified for severity of postmenstrual symptoms and history of major depression. Flexible sertraline dose was 50-100 mg/day. Outcome measures were the Daily Symptom Rating Form score and patient global ratings of functioning. RESULTS: Both sertraline groups improved significantly more than the placebo group as assessed by total premenstrual Daily Symptom Rating Form scores for 3 treatment months. Daily Symptom Rating Form factors that were significantly more improved in the sertraline groups were mood and physical symptoms. Sertraline improvement occurred swiftly in the first month of treatment. Gradual placebo improvement was similar to sertraline in the third month. Subjects with higher postmenstrual symptoms before treatment remained more symptomatic regardless of the dosing regimen. A history of major depression was not associated with treatment response. More sertraline-treated subjects reported improved functioning in the domains of family relationships, social activities, and sexual activity. CONCLUSIONS: Premenstrual dosing does not differ from continuous dosing with sertraline in premenstrual syndrome treatment. Higher levels of postmenstrual symptoms limit treatment response and are important to define in treatment of premenstrual syndrome.

Adolescent↗

PubMed2001

Prospective randomized multicenter comparison of high-frequency oscillatory ventilation and conventional ventilation in preterm infants of less than 30 weeks with respiratory distress syndrome.

BACKGROUND: Early use of high-frequency ventilation and exogenous surfactant is proposed as the optimal mode of ventilatory support in infants with respiratory distress syndrome. In very premature infants, we tested the hypothesis that high-frequency versus conventional ventilation could decrease exogenous surfactant requirements and improve pulmonary outcome, without altering the complication rate, including that of severe intraventricular hemorrhage. METHODS: Preterm infants with a postmenstrual age of 24 to 29 weeks, presenting with respiratory distress syndrome were randomly assigned to high-frequency oscillatory ventilation (lung volume recruitment strategy) or conventional ventilation. RESULTS: Two hundred seventy-three infants were enrolled. One hundred fifty-three had a postmenstrual age of 24 to 27 weeks, and 143 had a birth weight </=1000 g. One hundred thirty-four infants were randomized at 142 minutes of life (median) to receive conventional ventilation (mean postmenstrual age at birth: 27. 6 +/- 1.5 weeks; mean birth weight: 997 +/- 245 g); and 139 infants were randomized at 145 minutes of life to receive high-frequency ventilation (mean postmenstrual age at birth: 27.5 +/- 1.4 weeks; mean birth weight: 976 +/- 219 g). High-frequency ventilation, compared with conventional ventilation, was associated with a twofold reduction in the requirement for >/=2 instillations of exogenous surfactant (30% vs 62%; odds ratio:.27; 95% confidence interval:.16-.44) and no difference in pulmonary outcome. The incidence of severe intraventricular hemorrhage was 24% in the high-frequency group and 14% in the conventional ventilation group (adjusted odds ratio: 1.50; 95% confidence interval:.68-3.30). CONCLUSION: Early use of high-frequency oscillatory ventilation in very premature infants decreases exogenous surfactant requirements, does not improve the pulmonary outcome, and may be associated with an increased incidence of severe intraventricular hemorrhage.

Bronchopulmonary Dysplasia↗

PubMed2004

Impact of a physiologic definition on bronchopulmonary dysplasia rates.

OBJECTIVE: Bronchopulmonary dysplasia (BPD) is the endpoint of many intervention trials in neonatology, yet the outcome measure when based solely on oxygen administration may be confounded by differing criteria for oxygen administration between physicians. We previously reported a technique to standardize the definition of BPD between sites by using a timed room-air challenge in selected infants. We hypothesized that a physiologic definition of BPD would reduce the variation in observed rates of BPD among different neonatal centers. Methodology. A total of 1598 consecutive inborn premature infants (501-1249 g birth weight) who remained hospitalized at 36 weeks' postmenstrual age were prospectively assessed and assigned an outcome with both a clinical definition and physiologic definition of BPD. The clinical definition of BPD was oxygen supplementation at exactly 36 weeks' postmenstrual age. The physiologic definition of BPD was assigned at 36 +/- 1 weeks' postmenstrual age and included 2 distinct subpopulations. First, neonates on positive pressure support or receiving >30% supplemental oxygen with saturations between 90% and 96% were assigned the outcome BPD and not tested further. Second, those receiving < or =30% oxygen or effective oxygen >30% with saturations >96% underwent a room-air challenge with continuous observation and oxygen-saturation monitoring. Outcomes of the room-air challenge were "no BPD" (saturations > or =90% during weaning and in room air for 30 minutes) or "BPD" (saturation <90%). At the conclusion of the room-air challenge, all infants were returned to their baseline oxygen levels. Safety (apnea, bradycardia, increased oxygen use) and outcomes of the physiologic definition versus the clinical definition were assessed. RESULTS: A total of 560 (35.0%) neonates were diagnosed with BPD by the clinical definition of oxygen use at 36 weeks' postmenstrual age. The physiologic definition diagnosed BPD in 398 (25.0%) neonates in the cohort. All infants were safely studied. There were marked differences in the impact of the definition on BPD rates between centers (mean reduction: 10%; range: 0-44%). Sixteen centers had a decrease in their BPD rate, and 1 center had no change in their rate. CONCLUSIONS: The physiologic definition of BPD reduced the overall rate of BPD and reduced the variation among centers. Significant center differences in the impact of the physiologic definition were seen, and differences remained even with the use of this standardized definition. The magnitude of the change in BPD rate is comparable to the magnitude of treatment effects seen in some clinical trials in BPD. The physiologic definition of BPD facilitates the measurement of BPD as an outcome in clinical trials and the comparison between and within centers over time.

Apnea↗

PubMed2000

Predictors of response to sertraline treatment of severe premenstrual syndromes.

BACKGROUND: Serotonergic antidepressant medications have demonstrated efficacy in the treatment of severe premenstrual syndrome (PMS) and premenstrual dysphoric disorder (PMDD). Over 60% of subjects responded well to sertraline treatment for PMS and PMDD in double-blind controlled studies. However, no studies have evaluated the predictors of treatment response for this disorder. The current study examined pretreatment demographic, medical history, and clinical symptom predictors of sertraline response in PMS and PMDD treatment. METHOD: Sixty-two subjects diagnosed with severe PMS (according to the Daily Symptom Report and global ratings of functional impairment) or PMDD (DSM-IV) received sertraline treatment as part of a randomized, double-blind, placebo-controlled treatment efficacy study. All subjects completed 3 screening cycles, including a single-blind placebo washout cycle, prior to 3 cycles of double-blind treatment. Outcome was assessed across the domains of PMS symptoms and quality of life. Demographic, medical history, and symptom variables were used to predict sertraline response. RESULTS: Baseline postmenstrual symptom ratings were significantly and independently associated with posttreatment PMS symptoms in multivariate analysis. Premenstrual and postmenstrual ratings of depression, medical history variables, and demographic variables were not significantly predictive of response to sertraline. CONCLUSION: Baseline postmenstrual symptom ratings controlled for baseline premenstrual symptoms were associated with PMS symptoms at sertraline treatment endpoint. The findings suggest that nonmenstrual-related baseline characteristics other than depression may influence sertraline treatment outcome in patients with higher postmenstrual symptom levels.

Adolescent↗

PubMed2002

Evidence-based screening criteria for retinopathy of prematurity: natural history data from the CRYO-ROP and LIGHT-ROP studies.

BACKGROUND: The Multicenter Trial of Cryotherapy for Retinopathy of Prematurity (CRYO-ROP) demonstrated the efficacy of treatment for threshold ROP and indicated the need for worldwide ROP screening. Previous guidelines for ROP screening have been largely based on clinical impression; we can now develop evidence-based screening recommendations. OBJECTIVE: To define the appropriate ages and retinal ophthalmoscopic signs that determine when to commence and conclude acute phase ROP screening. DESIGN: Analysis of data from 2 prospective randomized controlled trials: CRYO-ROP (January 1, 1986, to November 30, 1987) and Light Reduction in ROP (LIGHT-ROP) (July 1, 1995, to March 31, 1997). SETTING: Neonatal intensive care units in 23 study centers in the United States for CRYO-ROP and 3 centers for LIGHT-ROP. PATIENTS: Eyes were examined sequentially in 4099 infants with birth weight less than 1251 g (CRYO-ROP study) and in 361 infants with birth weight less than 1251 g and gestational age less than 31 weeks (LIGHT-ROP study). RESULTS: In 99% of infants, retinal conditions indicating a risk of poor outcome were not observed before 31 weeks' postmenstrual age or 4 weeks' chronologic age. Signs indicating that the risk of visual loss from ROP was minimal or had passed were the infant's attainment of 45 weeks' postmenstrual age without the development of prethreshold ROP or worse, progression of retinal vascularization into zone III without previous zone II ROP, and full vascularization. CONCLUSIONS: The initial eye examination should be conducted by 31 weeks' postmenstrual age or 4 weeks' chronologic age, whichever is later. Acute phase ROP screening can be discontinued when any of the 3 signs is present, indicating that the risk of visual loss from ROP is minimal or passed.

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