NCT06731439 Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
| NCT ID | NCT06731439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Tennessee |
| Condition | Extra Uterine Growth Restriction |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 248 participants in total. It began in 2024-06-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Mohamad Elabiad, MD
PRINCIPAL INVESTIGATOR
UTHSC
Frequently Asked Questions
Who can join the NCT06731439 clinical trial?
This trial is open to participants of all sexes, aged 1 Minute or older, up to 6 Hours, studying Extra Uterine Growth Restriction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06731439 currently recruiting?
Yes, NCT06731439 is actively recruiting participants. Contact the research team at Melabiad@uthsc.edu for enrollment information.
Where is the NCT06731439 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT06731439 clinical trial?
NCT06731439 is sponsored by University of Tennessee. The principal investigator is Mohamad Elabiad, MD at UTHSC. The trial plans to enroll 248 participants.