Clinical Trial

Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?

Recruiting
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Record status
This record was last updated December 12, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Feeding advancements in ELBW infants have evolved over decades. The fear of causing mortality and morbidity, notably NEC, have made providers cautious when advancing feeds. ELBW infants initially remained NPO for several days before initiating trophic feeds. However, data then showed that there was no increase in mortality and morbidity if trophic feeds were initiated earlier. Then data showed that a short duration of trophic feeds did not increase mortality and morbidity when compared to a prolonged duration. More recent data showed that enteral feeding should be initiated early, preferably within 24 hours of birth, because it may promote feeding tolerance, shorten the time to reach total enteral feeding, and reduce the incidence of extrauterine growth restriction and late onset sepsis without increasing the risk of developing NEC. The management of enteral nutrition in ELBW infants is still very variable. For example, there is no consensus on the optimal time point after birth at which enteral nutrition can be started. This study evaluates the benefits of starting feeds by 6 hours of life Purpose: The primary aim of this study is to evaluate if in infants ≤ 1000g birth weight, is there a benefit initiating feeds by 6 hours of life (compared to current feeding practice data of 3 days of life) on decreasing the time to attain full feeds in the first 30 days of life. The secondary aim is to evaluate if antenatal feeding discussions would streamline feeding management post-delivery.
Trial Details
NCT Number NCT06731439
Lead Sponsor University of Tennessee
Conditions Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant
Enrollment 248 participants
Start Date 2024-06-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-12