Recruiting

Observational Study

Sponsor:

University of Tennessee

Code:

NCT06731439

Conditions

Extra Uterine Growth Restriction

Premature Infant Disease

VLBW - Very Low Birth Weight Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Starting feeds within 6 hours of life

Standard feeding protocol

Study Details

Brief 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

Study ID

NCT06731439

Start date

Jun 1, 2024

Status verified date

Dec, 2024

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

248 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Early feeding arm

active comparator: Control arm

Interventions

Starting feeds within 6 hours of life

Starting feeds within 6 hours of life

Standard feeding protocol

Starting feeds based on standard protocol as per primary team

Primary outcome measure

  • Day of life reaching full feeds [ Time Frame: From birth until day of life full feeds reached in the first 30 days of life ]

Central Contacts and Locations

Central contacts

Locations

Regional One Health

Recruiting

Memphis, Tennessee, United States, 38163

Contacts

More Information

Sponsor

University of Tennessee

Last update posted

Dec 12, 2024

Last verified

Dec, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Tennessee on 2024-12-12.