NCT06731439

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

Recruiting now NA Last updated 12 December 2024

What this trial tests

NA trial testing Starting feeds within 6 hours of life in Extra Uterine Growth Restriction in 248 participants. Currently enrolling.

Timeline

1 June 2024

Primary endpoint
30 June 2026

30 June 2027

Quick facts

Lead sponsor	University of Tennessee
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	248
Start date	1 June 2024
Primary completion	30 June 2026
Estimated completion	30 June 2027
Sites	1 location across United States

Drugs / interventions tested

• Starting feeds within 6 hours of life
• Standard feeding protocol

Conditions studied

• Extra Uterine Growth Restriction — all drugs for Extra Uterine Growth Restriction →
• Premature Infant Disease — all drugs for Premature Infant Disease →
• VLBW - Very Low Birth Weight Infant — all drugs for VLBW - Very Low Birth Weight Infant →

Sponsor

University of Tennessee

Who can join

Adults 1 Minute to 6 Hours, any sex, with Extra Uterine Growth Restriction or Premature Infant Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.