Recruiting
Phase 4

Zinc Supplementation

Sponsor:

Augusta University

Code:

NCT07896070

Conditions

Extreme Prematurity,Extremely Low Birthweight

BPD - Bronchopulmonary Dysplasia

Growth

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

1 mg/day Zinc Supplementation

3 mg/day Zinc Supplementation

Study Details

Brief summary:

Preterm infants born prematurely are more likely to have low zinc levels because they have less time to build up zinc before birth. They also have smaller zinc stores after birth and may need more zinc to support their rapid growth.

This study will examine how growth is affected in premature babies receiving either the current dose or a higher dose of zinc supplementation. The zinc supplement will be given daily, starting according to the unit's standard feeding guidelines, and will be stopped based on usual standard-of-care practices.

Possible risks of zinc supplementation include gastrointestinal intolerance (such as vomiting, diarrhea, or stomach discomfort) and anemia.

Possible benefits include improved growth, a stronger immune system, a shorter hospital stay, and lower healthcare costs.

Conditions

Extreme Prematurity,Extremely Low Birthweight

BPD - Bronchopulmonary Dysplasia

Growth

Study ID

NCT07896070

Start date

Aug 1, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lower Zinc Supplementation

Subjects will receive 1 mg/kg enteral zinc supplementation in accordance with the NICU feeding protocol. Supplementation will continue until discontinued per currently utilized standard of care (33-35 weeks PMA).

experimental: Higher Zinc Supplementation

Subjects will receive 3 mg/kg enteral zinc supplementation in accordance with the NICU feeding protocol. Supplementation will continue until discontinued per currently utilized standard of care (33-35 weeks PMA).

Interventions

1 mg/day Zinc Supplementation

Neonates in this arm will receive the lower standardized enteral zinc dosing

3 mg/day Zinc Supplementation

Neonates in this arm will receive the higher standardized enteral zinc dosing

Primary outcome measure

  • Weight Velocity [ Time Frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first. ]

Central Contacts and Locations

Central contacts

Julia Newman, DO

706-721-2331junewman@augusta.edu

Locations

Wellstar Childrens Hospital of Georgia

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Julia Newman, DO

(706) 721-2331junewman@augusta.edu

More Information

Sponsor

Augusta University

Last update posted

Oct 26, 2026

Last verified

Oct, 2026

Keywords

  • nutrition
  • Zinc
  • growth
  • prematurity
  • BPD- bronchopulmonary dysplasia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-27. This information was provided to ClinicalTrials.gov by Augusta University on 2026-10-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.