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

Recruiting now · Not applicable

Conditions studied: Extra Uterine Growth Restriction, Premature Infant Disease, VLBW - Very Low Birth Weight Infant

In brief

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.

Key facts

Study ID

NCT06731439

Run by

University of Tennessee

People needed

248

Starts

2024-06-01

Expected to finish

2027-06-30

Last updated by the study team

2024-12-12

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All infants less than or equal to 1000 g
• Clinical care team in agreement with patient's participation
• All mothers with pregnancies with EFW close to 1000g or less.

You may not qualify if…

• 1 congenital malformations that may affect gastro intestinal perfusion
• 2 Clinically progressing towards imminent death
• 3 congenital gastrointestinal obstructions
• 4 Mothers unlikely to deliver infants ≤ 1000g
• 5 Infant on pressors other than dopamine given at < 5mcg/kg/min. Dopamine is an exclusion if administered at a dose exceeding 5mcg/kg/min.
• 6 Mothers who are not in a sound mental state to be consented either to their critical condition, intubated, sedated, for examples
• 7 Mothers who are critically ill where by it is felt that mom will not be able to participate in the consent

Where it is running

• Regional One Health — Memphis, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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