Early feeding for premature infants to improve growth and health outcomes
Does Starting Feeds on the First Day of Life Help Premature Infants Reach Full Volume Feeds Sooner?
This study is testing if starting feedings within the first 6 hours of life can help very premature babies grow better and avoid health problems compared to those who start feeding later.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 248 (estimated) |
| Ages | 1 Minute to 6 Hours |
| Sex | All |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT06731439 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates whether starting enteral feeds within the first 6 hours of life can help extremely low birth weight (ELBW) infants reach full feeding volumes sooner. The study aims to address barriers to early feeding initiation, such as the need for parental consent for donor breast milk, which often delays feeding until the third day of life. By comparing the outcomes of infants who receive early feeding against those who follow standard feeding protocols, the trial seeks to determine the impact on growth, feeding tolerance, and the incidence of complications like necrotizing enterocolitis (NEC).
Who should consider this trial
Good fit: Ideal candidates for this study are infants weighing 1000 grams or less at birth whose clinical care team agrees to their participation.
Not a fit: Patients with congenital malformations affecting gastrointestinal function or those in critical condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved growth and reduced complications for premature infants.
How similar studies have performed: Previous studies have shown promising results for early enteral feeding in similar populations, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Memphis, Tennessee
- Regional One Health — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Mohamad Elabiad, MD — Uthsc
- Study coordinator: Mohamad Elabiad, MD
- Email: Melabiad@uthsc.edu
- Phone: 901-448-4751
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.