Higher zinc supplementation to boost weight gain in extremely premature infants
Official title: Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
Run by Augusta University · NCT07896070 · Data updated 2026-11-12
This study tests whether giving preterm babies a higher daily dose of zinc helps them gain weight faster than the current dose.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 25 Weeks to 34 Weeks |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Augusta University Academic / other |
| Locations | 1 site (Augusta, Georgia) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | May 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07896070 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Infants born between 750 and 1500 grams at birth who are in a NICU and not on formula milk, with no major GI anomalies or NEC/SIP.
✕Probably not a fit
Infants who do not respond to higher zinc dose or who develop safety concerns may not experience growth benefits.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Premature infants are at risk for zinc deficiency due to limited in utero accumulation and small zinc stores after birth. This open-label randomized trial compares two zinc dosing regimens, 1 mg/kg/day versus 3 mg/kg/day, from birth to 36 weeks PMA or discharge, to see which improves weight velocity. Secondary outcomes include head circumference and length velocity, bronchopulmonary dysplasia severity, and length of hospital stay. Safety monitoring will note possible GI intolerance and anemia. Conducted at Wellstar Children's Hospital of Georgia with Augusta University as sponsor, the study follows standard NICU feeding practices with dose adjustments per usual care.
Why it matters
Potential benefit: If successful, higher zinc dosing could improve growth and reduce hospital stay for extremely preterm infants.
How similar studies have gone: Previous research suggests zinc supports growth in preterm infants, but this exact dosing comparison is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Birth weight: 750-1500 grams Exclusion Criteria: * Spontaneous Intestinal Perforation (SIP) * Necrotizing enterocolitis (NEC) * Gastrointestinal anomalies (gastroschisis, omphalocele, or intestinal atresia) * Infants on formula milk
Where it's running
-
Wellstar Childrens Hospital of Georgia
Augusta, Georgia, United States Recruiting
Study contacts
- Principal investigator: Lauren Walker, DO — Augusta University
- Study coordinator: Julia Newman, DO
- Email: junewman@augusta.edu
- Phone: 706-721-2331
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.