The most immature infants: Is evidence-based practice possible?

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.