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Postnatal phenobarbitone for the prevention of intraventricular hemorrhage in preterm infants
1Child Health, University of Bristol, Southmead Hospital, Bristol, UK, BS10 5NB. andrew.whitelaw@bristol.ac.uk
Insights
Postnatal phenobarbitone did not reduce intraventricular hemorrhage (IVH) risk in preterm infants. This treatment was associated with an increased need for mechanical ventilation, making it not recommended for IVH prevention.
Area of Science:
- Neonatal medicine
- Pediatric neurology
- Clinical pharmacology
Background:
- Intraventricular hemorrhage (IVH) is a significant concern in preterm infants.
- Phenobarbitone has been investigated for its potential prophylactic effects against IVH.
Purpose of the Study:
- To evaluate the efficacy of postnatal phenobarbitone in reducing the risk of IVH in preterm infants.
- To assess the impact of phenobarbitone on neurodevelopmental impairment and mortality.
Main Methods:
- Systematic review and meta-analysis of randomized and quasi-randomized controlled trials.
- Included preterm infants at risk for IVH (gestational age < 34 weeks, birthweight < 1500 g, or respiratory failure).
- Outcomes assessed included IVH, posthemorrhagic ventricular dilatation, neurodevelopmental impairment, death, and adverse effects.
Main Results:
- Nine trials involving 740 infants were analyzed.
- No significant difference was found in the incidence of IVH, severe IVH, posthemorrhagic ventricular dilatation, neurodevelopmental impairment, or death between phenobarbitone and control groups.
- A significant increase in the need for mechanical ventilation was observed in infants receiving phenobarbitone.
Conclusions:
- Postnatal phenobarbitone administration is not recommended for preventing IVH in preterm infants.
- The use of phenobarbitone is associated with an increased requirement for mechanical ventilation.
Background:
This section is under preparation and will be included in the next issue.
Objectives:
To determine whether postnatal administration of phenobarbitone to preterm infants reduces the risk of intraventricular hemorrhage (IVH), neurodevelopmental impairment or death.
Search Strategy:
See the Search Strategy of the Neonatal Collaborative Review Group. The reviewer has been a active trialist in this area and has personal contact with many groups in this field. Journals handsearched from 1976 (when cranial CT scanning started) to November 1998 include: Pediatrics, J Pediatrics, Archives of Disease in Childhood, Pediatric Research, Developmental Medicine and Child Neurology, Acta Paediatrica, European J of Pediatrics, Neuropediatrics, New England J of Medicine, Lancet and British Medical J. The National Library of Medicine (USA) database (via PubMed) and the Cochrane Controlled Trials Register were searched through to November 1998 using the MeSH terms intraventricular hemorrhage, newborn infants, premature infant, intracranial hemorrhage, phenobarbitone, phenobarbital. The searches were not limited to the English language, as long as the article included an English abstract. Promising articles were read in the original language or translated.
Selection Criteria:
Included were randomized or quasi-randomized controlled trials in which phenobarbitone was given to preterm infants identified as being at risk of IVH because of gestational age below 34 weeks, birthweight below 1500 g, or respiratory failure. Adequate determination of IVH by ultrasound or CT was also required.
Data Collection And Analysis:
In addition to details of patient selection and control of bias, the details of the administration of phenobarbitone were extracted. The end-points searched for included: IVH ( with grading), posthemorrhagic ventricular dilatation or hydrocephalus, neurodevelopmental impairment and death. In addition, possible adverse effects of phenobarbitone such as hypotension, mechanical ventilation, pneumothorax, hypercapnia, and acidosis were searched for.
Main Results:
Nine controlled trials were included with 740 infants recruited. There was heterogeneity between trials for the outcome IVH, with one trial finding a significant decrease in IVH and another trial finding an increase in IVH in the group receiving phenobarbitone. Meta-analysis showed no difference between the phenobarbitone treated group and the control group in either IVH (typical relative risk 1.04, CI 0.87, 1.25), severe IVH (typical relative risk 0.91, CI 0.66, 1.27), posthemorrhagic ventricular dilatation (typical relative risk 0.89, CI 0.38, 2.08), severe neurodevelopmental impairment (typical relative risk 1.44, CI 0.41, 5.04) or death before hospital discharge (typical relative risk 0.88, CI 0.64, 1.21) There was a consistent trend in the trials towards increased use of mechanical ventilation in the phenobarbitone treated group, which was supported by the meta-analysis (typical relative risk 1.18, CI 1.06, 1.32; typical risk difference 0.129, CI 0.045, 0.213), but there was no significant difference in pneumothorax, acidosis or hypercapnia.
Reviewer'S Conclusions:
Postnatal administration of phenobarbitone cannot be recommended as prophylaxis to prevent IVH in preterm infants and is associated with an increased need for mechanical ventilation.