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Biomedical subjects

V S Shah

Publications and source records attributed to V S Shah.

7 recordsLinked to original sources

Inhaled versus systemic corticosteroids for the treatment of chronic lung disease in ventilated very low birth weight preterm infants.

BACKGROUND: Chronic lung disease (CLD) remains a serious and common problem among very low birth weight infants despite the use of antenatal steroids and postnatal surfactant therapy to decrease the incidence and severity of respiratory distress syndrome. Corticosteroids have been widely used to treat or prevent CLD due to their anti-inflammatory properties. However, the use of systemic steroids has been associated with serious short and long term adverse effects. Administration of corticosteroids topically through the respiratory tract might result in beneficial effects on the pulmonary system with fewer undesirable systemic side effects. OBJECTIVES: To compare the effectiveness of inhaled versus systemic corticosteroids administered to ventilator dependent preterm neonates with birth weight </= 1500 grams or gestational age </= 32 weeks after two weeks of life for the treatment of evolving CLD. SEARCH STRATEGY: Randomized and quasi-randomized trials were identified by searching the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1980 - September 2002), CINAHL (1982 - September 2002), reference lists of published trials and abstracts published in Pediatric Research (1990 - April 2002) from the Society for Pediatric Research/Pediatric Academic Societies' Annual Meetings. SELECTION CRITERIA: Randomized or quasi-randomized trials comparing inhaled versus systemic corticosteroid therapy (irrespective of the dose and duration of therapy) starting after the first two weeks of life in ventilator dependent very low birth weight preterm neonates. DATA COLLECTION AND ANALYSIS: Data were extracted regarding clinical outcomes including CLD at 28 days or 36 weeks corrected gestational age (CGA), mortality, combined outcome of death or CLD at 28 days or 36 weeks CGA, other pulmonary outcomes and adverse effects. All data were analyzed using RevMan 4.1. When appropriate, meta-analysis was performed using relative risk (RR), risk difference (RD), and weighted mean difference (WMD) along with their 95% confidence intervals (CI). If RD was statistically significant, number needed to treat (NNT) was calculated. MAIN RESULTS: Five trials comparing inhaled versus systemic corticosteroids in the treatment of CLD were identified. Two trials were excluded as both included non ventilator dependent patients. One trial is awaiting assessment and clarification of published data. Two trials qualified for inclusion in this review. Halliday et al (Halliday 2001a) randomized infants < 72 hours, while Suchomski et al (Suchomski 2002) randomized at 12-21 days. Although the steroids were commenced after the first 2 weeks of life in both the trials, the outcomes were measured over different time periods, from the age at randomization in each trial, making it inappropriate to combine results. In neither trial was there a statistically significant difference between the groups in the incidence of CLD at 36 weeks CGA amongst all randomized infants. The estimates for the trial by Halliday et al (Halliday 2001a) were RR 1.10 (95% CI 0.82, 1.47), RD 0.03 (95% CI -0.08, 0.15); number of infants (n) = 292 and for the trial by Suchomski et al (Suchomski 2002) RR 0.90 (95% CI 0.79, 1.02), RD -0.10 (95% CI -0.22, 0.02; n = 78 ). There were no statistically significant differences between the groups in either trial for oxygen dependency at 28 days, death by 28 days or 36 weeks, the combined outcome of death or CLD by 28 days or 36 weeks CGA, duration of intubation, duration of oxygen dependence, or adverse effects. Information on the long term neurodevelopmental outcomes was not available. REVIEWER'S CONCLUSIONS: This review found no evidence that inhaled corticosteroids confer net advantages over systemic corticosteroids in the management of ventilator dependent preterm infants. Neither inhaled steroids, nor systemic steroids, can be recommended as standard treatment for ventilated preterm infants. There was no evidence of difference in effectiveness or side-effect profiles for inhaled versus systemic steroids. A better delivery system guaranteeing selective delivery of inhaled steroids to the alveoli might result in beneficial clinical effects without increasing side-effects. To resolve this issue, studies are needed to identify the risk/benefit ratio of different delivery techniques and dosing schedules for the administration of these medications. The long term effects of inhaled steroids, with particular attention to neurodevelopmental outcome, should be addressed in future studies.

Administration, Inhalation↗

Inhaled versus systemic corticosteroids for preventing chronic lung disease in ventilated very low birth weight preterm neonates.

BACKGROUND: Chronic lung disease (CLD) remains an important cause of mortality and morbidity in preterm infants despite the administration of antenatal corticosteroids, surfactant replacement therapy and other advances in neonatal intensive care. There is increasing evidence from cellular and biochemical research that inflammation plays an important role in the pathogenesis of CLD. Thus, interventions aimed at reducing or modulating the inflammatory process may reduce the incidence or severity of CLD. Theoretically, the use of inhaled corticosteroids may allow for beneficial effects on the pulmonary system without concomitant high systemic concentrations and less risk of adverse effects. OBJECTIVES: To compare the effectiveness of inhaled versus systemic corticosteroids, started within the first two weeks of life, in preventing CLD in ventilated very low birth weight infants. SEARCH STRATEGY: Randomized and quasi-randomized trials were identified by searching the Cochrane Controlled Trials Register (The Cochrane Library, Issue 3, 2002), MEDLINE (1966 - September 2002), EMBASE (1980 - September 2002), CINAHL (1982 - September 2002), reference lists of published trials and abstracts published in Pediatric Research (1990 - April 2002) from the Society of Pediatric Research/ Pediatric Academic Society's annual meetings. SELECTION CRITERIA: Randomized or quasi-randomized clinical trials comparing inhaled versus systemic corticosteroid therapy (regardless of the dose and duration of therapy), started in first two weeks of life in very low birth weight preterm infants receiving assisted ventilation. DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including CLD at 28 days or 36 weeks corrected gestational age (CGA), mortality, combined outcome of death or CLD at 28 days or 36 weeks CGA, other pulmonary outcomes and adverse effects were evaluated. All data were analyzed using RevMan 4.1. When appropriate, meta-analysis was performed using relative risk (RR), risk difference (RD), and weighted mean difference (WMD) along with their 95% confidence intervals (CI). If RD was significant, number needed to treat (NNT) or number needed to harm (NNH) was calculated. MAIN RESULTS: Two trials qualified for inclusion in this review. There was an increase in the incidence of CLD at 36 weeks CGA in the inhaled steroid group amongst all randomized infants, which was of borderline statistical significance: [RR 1.45 (95% CI 0.99, 2.11); RD 0.11 (95% CI 0.00, 0.21), p = 0.05, 1 trial and n = 278]. There was no statistically significant difference in the incidence of CLD at 36 weeks amongst all survivors [RR 1.34 (95% CI 0.94, 1.90); RD 0.11(95% CI -0.02, 0.24), 1 trial and n = 206]. There were no statistically significant differences for oxygen dependency at 28 days (2 trials and n = 294), death by 28 days (2 trials and n = 294) or 36 weeks (2 trials and n = 294) and the combined outcome of death or CLD by 28 days (2 trials and n = 294) or 36 weeks CGA (1 trial and n = 278). The duration of mechanical ventilation was statistically significantly longer in the inhaled as compared to the systemic steroid group (WMD 3.89 days, 95% CI 0.24, 7.55; 2 trials and n = 294). The duration of supplemental oxygen was statistically significantly longer in the inhaled as compared to the systemic steroid group (WMD 11.10 days, 95% CI 1.97, 20.22; 2 trials and n = 294). There was a significantly lower incidence of hyperglycemia in the group receiving inhaled steroids (RR 0.52, 95% CI 0.39,0.71; RD -0.25, 95% CI -0.37, -0.14; 1 trial and n = 278). The NNT was 4.0 (95% CI 2.7, 7.14) to avoid one infant experiencing hyperglycemia. There was a statistically significant increase in the rate of patent ductus arteriosus (RR 1.64, 95% CI 1.23, 2.17; RD 0.21, 95% CI 0.10, 0.33; 1 trial and n = 278) in the group receiving inhaled steroids. The NNH was 4.8, 95% CI 3, 10. There were decreases of borderline statistical significance in the incidences of gastrointestinal hemorrhage and gastrointestinal perforation in the inhaled as compared to systemic steroid group: for gastrointestinal hemorrhage, RR 0.40, 95% CI 0.16, 1.02; RD -0.06, 95% CI -0.12, 0.00, p = 0.05 (1 trial and n = 278); for gastrointestinal perforation, RR 0.16, 95% CI 0.02, 1.29; RD -0.04, 95% CI -0.07, 0.00, p = 0.05 (1 trial and n = 278). The incidence of other side effects was not statistically significantly different in the two groups. No information was available on long term neurodevelopmental outcomes. REVIEWER'S CONCLUSIONS: This review found no evidence that early inhaled steroids confer important advantages over systemic steroids in the management of ventilator dependent preterm infants. Neither inhaled steroids, nor systemic steroids, can be recommended as a part of standard practice for ventilated preterm infants. Because they might have fewer adverse effects than systemic steroids, further randomized controlled trials of inhaled steroids are needed which address risk/benefit ratio of different delivery techniques, dosing schedules and long term effects, with particular attention to neurodevelopmental outcome.

Administration, Inhalation↗

Is venepuncture in neonatal research ethical?

AIM: To determine whether venepuncture accords with the accepted (BPA) criteria of not causing more than minimal physical or psychological distress during non-therapeutic research. METHODS: Ninety two venepunctures were carried out in 69 neonates between days 6 and 10 of life, and in some cases, on day 28. Parents were fully informed of the need for the procedure and allowed to attend while it was performed. Ninety parents and 87 doctors completed questionnaires to assess the levels of perceived parental and child distress and anxiety before and after the procedure. RESULTS: Only three parents were very upset, and 47% reported the test as being better than they expected, compared with 10% who thought it worse than expected. Seven babies were recorded as being very upset. Doctors tended to underestimate the degree of anxiety before the procedure and the level of distress afterwards. CONCLUSIONS: Venepuncture in neonates seems to be acceptable to most parents and is associated with a favourable risk: benefit ratio using semiquantitative assessment of risk and benefit.

Anxiety↗

Neonatal pain response to heel stick vs venepuncture for routine blood sampling.

Neonatal pain response and adverse effects and maternal anxiety were assessed in 27 infants who were randomly allocated to venepuncture or heel stick. Pain was assessed by nurses using the Neonatal Infant Pain Scale (NIPS) and a three point scale for the mothers. NIPS scores were higher in the heel stick group compared with the venepuncture group. Maternal anxiety was higher before the procedure while perception of an infant's pain was lower in the venepuncture group compared with the heel stick group. Venepuncture is less painful than heel stick in newborn infants undergoing routine blood sampling.

Anxiety↗

EEG recognition of holoprosencephaly and Aicardi syndrome.

Two cases of alobar holoprosencephaly and two of Aicardi syndrome are reported for their highly specific electroencephalographic (EEG) changes. The asynchronous sharp waves and spikes over the frontal regions with decreasing gradient of potential to the occipital leads were seen in alobar holoprosencephaly while burst suppression pattern with total asynchrony between the two hemispheres was seen in Aicardi syndrome. Even though EEG changes cannot be pathognomic of any abnormality, it is suggested that as in conditions like subacute sclerosing panencephalitis and petitmal epilepsy, so also in alobar holoprosencephaly and Aicardi syndrome, the characteristic features seen on EEG may provide the initial clue to the correct diagnosis.

Abnormalities, Multiple↗

Experience with the International League Against Epilepsy classifications of epileptic seizures (1981) and epilepsies and epileptic syndrome (1989) in epileptic children in a developing country.

Four hundred eighty-three epileptic children attending the Pediatric Epilepsy Clinic at Bai Jerbai Wadia Hospital for Children, Bombay, India were classified according to the International League Against Epilepsy (ILAE) classification of epileptic seizures (1981) and epilepsies and epileptic syndromes (1989). The predominant seizures were partial (53.6), generalized (40.3%), and unclassifiable (6%). In epilepsies and epileptic syndromes, 55.3% were partial, 27% were generalized, 13.5% were undetermined, and 4.1% were special syndromes. Although our results were similar in many respects to those of other reported series, some differences were observed in the incidence of partial and generalized seizures, and partial and generalized epileptic syndromes and their subgroups, such as idiopathic, symptomatic, and cryptogenic partial syndromes, idiopathic generalized syndromes, and symptomatic specific syndromes. These differences are probably due to different age limits, methods of case ascertainment and inclusion criteria, different genetic and environmental factors, variable interpretation of clinical and EEG features, and lack of facilities for investigation in developing countries. Despite various limitations, we were able to classify most cases; the ILAE classification can be used in developing countries so that comparison can be made with other studies.

Adolescent↗