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

NCT06731439 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 248

Last updated 2024-12-12

No results posted yet for this study

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.

Conditions

  • Extra Uterine Growth Restriction
  • Premature Infant Disease
  • VLBW - Very Low Birth Weight Infant

Interventions

OTHER

Starting feeds within 6 hours of life

Starting feeds within 6 hours of life

OTHER

Standard feeding protocol

Starting feeds based on standard protocol as per primary team

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Mohamad Elabiad, MD · UTHSC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Minute
Max Age
6 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06731439 on ClinicalTrials.gov