Actively Recruiting

Phase Not Applicable
Age: 1Minute - 6Hours
All Genders
NCT06731439

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

Led by University of Tennessee · Updated on 2024-12-12

248

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Minute - 6Hours
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Infants with birth weight less than or equal to 1000 grams
  • Agreement from the clinical care team for infant's participation
  • Mothers with pregnancies expecting infants weighing close to or less than 1000 grams
Not Eligible

You will not qualify if you...

  • Presence of congenital malformations affecting gastrointestinal blood flow
  • Infants clinically progressing towards imminent death
  • Presence of congenital gastrointestinal obstructions
  • Mothers unlikely to deliver infants weighing 1000 grams or less
  • Infant receiving more than one pressor or dopamine at doses exceeding 5 mcg/kg/min
  • Mothers not in a sound mental state for consent due to critical illness, sedation, or intubation
  • Mothers critically ill and unable to participate in consent process

AI-Screening

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Trial Site Locations

Total: 1 location

1

Regional One Health

Memphis, Tennessee, United States, 38163

Actively Recruiting

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Research Team

M

Mohamad Elabiad, MD

CONTACT

I

Ihinosen Edgal, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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