Early feeding for premature infants to improve growth and health outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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).

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.