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The most immature infants: Is evidence-based practice possible?
1CHU Sainte Justine, Montréal, Québec, Canada.
Insights
Evidence for caring for extremely premature infants is limited. Randomized controlled trials (RCTs) often exclude these vulnerable infants, hindering effective treatment decisions for neonates under 25 weeks gestational age (GA).
Area of Science:
- Neonatal Medicine
- Clinical Trials
- Evidence-Based Practice
Background:
- Infants born at extremely low gestational ages (<25 weeks) are physiologically immature.
- Their responses to clinical interventions may differ significantly from more mature preterm infants.
- Decisions for their care rely on limited available evidence.
Purpose of the Study:
- To assess the evidence base for clinical care decisions in extremely immature preterm infants.
- To evaluate the representation of infants <25 weeks gestational age in recent neonatal randomized controlled trials (RCTs).
Main Methods:
- Literature search of recent large neonatal RCTs.
- Analysis of infant representation by gestational age, specifically focusing on infants <25 weeks.
- Examination of whether trial results were presented for the most immature infants.
Main Results:
- Many recent RCTs excluded extremely immature infants (<25 weeks GA).
- Of over 25,000 infants (<32 weeks GA) in 30 trials, only 8 reported outcomes for <26 weeks GA (2,152 infants) and 4 for <25 weeks GA (711 infants).
- Results for the most at-risk, immature infants were rarely presented separately.
Conclusions:
- The evidence base for treating extremely preterm infants (<25 weeks GA) is severely limited.
- RCTs should include, not exclude, the most immature infants, regardless of gestational age or weight.
- Separate reporting of results for infants aged 22-24 weeks GA is crucial for developing effective treatments.
Introduction:
At extremely low gestational ages, preterm infants are markedly physiologically immature, thus their responses to common clinical interventions may differ from more mature preterm babies. This study was performed to describe the evidence base which is available to make care decisions for such infants.
Methods:
A literature search of recent large neonatal randomized controlled trials (RCTs) was performed to determine the representation of infants <25 weeks of gestation, and whether it is clear if the overall results applied to the most immature infants.
Results:
Among 30 multi-centre RCTs in neonatology from the last 5 years, many excluded the most immature infants, and those that included them rarely presented the impacts of the intervention on the most at-risk group. Over 25,000 infants of under 32 weeks gestational age (GA) were included in these trials. Eight trials presented results of the primary outcome for infants of <26 weeks GA (n = 2,152) and a further four trials for infants <25 weeks, n = 711.
Conclusion:
The evidence base for treatment decisions for the highest risk infants in the NICU is severely limited. RCTs in extremely preterm infants should not exclude the highest risk group, and lower limits of gestational age (or body weight) should be avoided, any infant receiving intensive care should be eligible regardless of how immature. The results among the most immature infants should be presented separately, or be easily available, in order to build a database of effective treatments among infants of 22,23, and 24 weeks GA.
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