A Phase 4 interventional study of 1 mg/day Zinc Supplementation and 3 mg/day Zinc Supplementation in Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia and Growth, sponsored by Augusta University. Recruiting at 1 site in United States. Open to participants aged 25 Weeks to 34 Weeks. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Augusta University · Phase 4, Interventional, and Treatment
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.
The purpose of this open label randomized control study is to evaluate whether zinc supplementation administered at higher recommended dose that is within established safety limits improves neonatal weight velocity compared with current supplementation. The primary objective of this study is to assess an increase in weight velocity in preterm infants receiving a FDA approved zinc supplementation dose of 3 mg/kg/day compared with 1 mg/kg/day (minimum 1 mg/day to ensure dose is measurable) from birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first. Secondary objectives include head circumference and length velocity from birth to 36 weeks PMA, grade of bronchopulmonary dysplasia at 36 weeks PMA, and length of stay.
342 studies on the registry are indexed under Bronchopulmonary Dysplasia; 81 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 230 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Augusta University is the lead sponsor of 180 studies on the registry; 26 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
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Exclusion Criteria:
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).
Drug: 1 mg/day 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).
Drug: 3 mg/day Zinc Supplementation
Neonates in this arm will receive the lower standardized enteral zinc dosing
Neonates in this arm will receive the higher standardized enteral zinc dosing
Weight Velocity
Increase in weight velocity in preterm infants receiving a FDA approved zinc supplementation dose of 3 mg/kg/day compared with 1 mg/kg/day.
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Head circumference
Change in head circumference in preterm infants receiving a FDA approved zinc supplementation dose of 3 mg/kg/day compared with 1 mg/kg/day.
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Length velocity
Change in length velocity in preterm infants receiving a FDA approved zinc supplementation dose of 3 mg/kg/day compared with 1 mg/kg/day.
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Grade of bronchopulmonary dysplasia
Severity of BPD diagnosis
Time frame: At 36 weeks post-menstrual age (PMA)
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Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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