Enteral Zinc Supplementation in Very Low Birth Weight Infants
Launched by UNIVERSITY OF TENNESSEE · May 23, 2024
Trial Information
Current as of June 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether giving a zinc supplement can help very low birth weight infants gain weight more effectively. Very low birth weight infants are those who weigh less than 1500 grams at birth. The researchers want to find out if providing 1 mg of zinc per kilogram of the baby's weight each day will improve their weight gain compared to infants who do not receive the supplement. Babies who are eligible for this study must be at least 25 weeks old and be able to tolerate at least 100 ml of feeding per kilogram of their body weight each day.
Participants in this trial will be divided into two groups. One group will receive the zinc supplement, while the other group will receive a similar amount of sterile water, so they won't know which group they are in. This is called a placebo. The zinc treatment will continue until the baby reaches 36 weeks of age or is discharged from the hospital, whichever comes first. Throughout the study, the babies will have their zinc levels checked to monitor how their bodies are responding. This trial aims to improve the nutritional care of very low birth weight infants, helping them grow stronger and healthier.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Birth weight \< 1500 grams
- • 2. Infant is tolerating at least 100 ml/kg/day of enteral feeds
- • 3. At least 25wks PMA.
- Exclusion Criteria:
- • Major congenital malformations especially anomaly of the GI tract
- • Major congenital heart disease (i.e.: ductal dependent lesion)
- • Previously diagnosed necrotizing enterocolitis (stage 2 or 3), bowel perforation, or bowel resection
- • Infant who has tolerated ≥100 ml/kg/day prior to admission.
About University Of Tennessee
The University of Tennessee is a leading research institution dedicated to advancing healthcare through innovative clinical trials. With a commitment to improving patient outcomes and fostering scientific discovery, the university engages in a diverse range of studies that encompass various medical disciplines. Leveraging its extensive resources, expert faculty, and state-of-the-art facilities, the University of Tennessee collaborates with healthcare professionals and industry partners to translate research findings into practical applications. Through rigorous ethical standards and a patient-centered approach, the university aims to contribute significantly to the field of medicine and enhance the well-being of communities.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Andrew C Mire, M.D.
Principal Investigator
UTHSC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported