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Randomised controlled trial of allopurinol prophylaxis in very preterm infants
1Department of Child Health, Liverpool Maternity Hospital.
Insights
Allopurinol did not prevent major complications like periventricular leucomalacia in preterm infants. Higher hypoxanthine levels were linked to these conditions, suggesting oxidative injury plays a role.
Area of Science:
- Neonatal Medicine
- Pharmacology
- Biochemistry
Background:
- Neonatal intensive care can involve oxidative injury.
- Xanthine oxidase generates superoxide radicals during hypoxiaischaemia.
- Complications like PVL, BPD, and ROP may stem from oxidative stress.
Purpose of the Study:
- To investigate allopurinol's efficacy in preventing neonatal intensive care complications.
- To assess if allopurinol can mitigate oxidative injury in preterm infants.
Main Methods:
- A randomized trial involving 400 preterm infants (24-32 weeks gestation).
- Infants received either enteral allopurinol or placebo for seven daily doses.
- Plasma hypoxanthine levels were measured at admission.
Main Results:
- No significant difference in periventricular leucomalacia (PVL) between allopurinol and placebo groups.
- Higher plasma hypoxanthine concentrations were observed in infants who developed PVL, BPD, or ROP.
- Allopurinol prophylaxis failed to prevent the primary endpoint (PVL).
Conclusions:
- Allopurinol was ineffective in preventing major complications in this study group.
- The timing of treatment and complexity of pathological processes may explain the failure.
- Alternative or combination therapies might be needed if oxidant injury is a key factor.
Abstract:
Allopurinol, an inhibitor of xanthine oxidase (an enzyme capable of generating superoxide radicals following hypoxiaischaemia), was investigated in preterm infants to determine its ability to prevent the complications of neonatal intensive care which may be associated with oxidative injury. Four hundred infants of between 24 and 32 weeks' gestation were randomly allocated to receive enteral allopurinol (20 mg/ml) or an equivalent dose of placebo for seven daily doses. At admission, plasma hypoxanthine concentrations were significantly higher in infants who subsequently developed periventricular leucomalacia (PVL), bronchopulmonary dysplasia (BPD), or retinopathy of prematurity (ROP), but there was no difference in the primary endpoint (PVL) between the treated and control groups. The failure of allopurinol prophylaxis in this group of infants is probably related to the complex nature of the pathological processes and to the timing of treatment. If oxidant injury is an important mechanism of cellular injury in these preterm infants, an alternative biochemical modulator would be required, or a combination of agents might be effective.
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