Extreme Prematurity,Extremely Low BirthweightPhase 4NCT07896070
Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
A Phase 4 study testing 1 mg/day Zinc Supplementation and 3 mg/day Zinc Supplementation in people with Extreme Prematurity,Extremely Low Birthweight and BPD - Bronchopulmonary Dysplasia, run by Augusta University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 34 weeks
- Conditions the study is for
- Extreme Prematurity,Extremely Low Birthweight, BPD - Bronchopulmonary Dysplasia, Growth
- What is being tested?
- 1 mg/day Zinc Supplementation and 3 mg/day Zinc Supplementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight: 750-1500 grams
Who cannot join
- Spontaneous Intestinal Perforation (SIP)
- Necrotizing enterocolitis (NEC)
- Gastrointestinal anomalies (gastroschisis, omphalocele, or intestinal atresia)
- Infants on formula milk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wellstar Childrens Hospital of Georgia
Augusta, Georgia, 30912
Julia Newman, DO, (706) 721-2331, junewman@augusta.edu
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- 1 mg/day Zinc Supplementation, 3 mg/day Zinc Supplementation
- Keywords
- nutrition, Zinc, growth, prematurity, BPD- bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg/day Zinc SupplementationDrug
Neonates in this arm will receive the lower standardized enteral zinc dosing
3 mg/day Zinc SupplementationDrug
Neonates in this arm will receive the higher standardized enteral zinc dosing
| Study group | Role | What they receive |
|---|---|---|
| Lower Zinc Supplementation | Experimental | 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). Receives: Drug: 1 mg/day Zinc Supplementation |
| Higher Zinc Supplementation | Experimental | 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). Receives: Drug: 3 mg/day Zinc Supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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
Measured: At 36 weeks post-menstrual age (PMA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start1 Aug 2026
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extreme Prematurity,Extremely Low BirthweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Preterm infants with a low birth weight admitted to the NICU at WellStar Children's Hospital of Georgia are placed on the unit feeding protocol and receive enteral zinc supplementation as part of standard care. After written informed parental permission is obtained, enrolled participants will be randomized in a 1:1 ratio using blocked randomization to receive either the standard-of-care lower dose of zinc (1 mg/kg/day) or the standard-of-care higher dose of zinc (3 mg/kg/day). Randomization will occur prior to initiation of the assigned dosing regimen.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Newman, Augusta University
- Investigators
- Lauren Walker, DO, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896070
- Sponsor's protocol ID
- 2437513-2
- Status last verified
- Oct 2026
- First submitted
- 5 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Higher Zinc Supplementation on Neonatal Weight Velocity
- ClinicalTrials.gov ID
- NCT07896070
- Acronym / sponsor ID
- 2437513-2
- Keywords
- nutrition, Zinc, growth, prematurity, BPD- bronchopulmonary dysplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Preterm infants with a low birth weight admitted to the NICU at WellStar Children's Hospital of Georgia are placed on the unit feeding protocol and receive enteral zinc supplementation as part of standard care. After written informed parental permission is obtained, enrolled participants will be randomized in a 1:1 ratio using blocked randomization to receive either the standard-of-care lower dose of zinc (1 mg/kg/day) or the standard-of-care higher dose of zinc (3 mg/kg/day). Randomization will occur prior to initiation of the assigned dosing regimen.
| Arm | Type | Receives |
|---|---|---|
| Lower Zinc Supplementation | Experimental | Drug: 1 mg/day Zinc SupplementationSubjects 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). |
| Higher Zinc Supplementation | Experimental | Drug: 3 mg/day Zinc SupplementationSubjects 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). |
Who may qualify
- Ages
- 25 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birth weight: 750-1500 grams
Key exclusion criteria (4 listed)
- Spontaneous Intestinal Perforation (SIP)
- Necrotizing enterocolitis (NEC)
- Gastrointestinal anomalies (gastroschisis, omphalocele, or intestinal atresia)
- Infants on formula milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1 mg/day Zinc SupplementationNeonates in this arm will receive the lower standardized enteral zinc dosing | Drug | Lower Zinc Supplementation |
| 3 mg/day Zinc SupplementationNeonates in this arm will receive the higher standardized enteral zinc dosing | Drug | Higher Zinc Supplementation |
Primary outcome
Weight Velocity
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
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.
3 secondary outcomes
Head circumference
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Length velocity
Time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.
Grade of bronchopulmonary dysplasia
Time frame: At 36 weeks post-menstrual age (PMA)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Enteral zinc supplementation for prevention of morbidity and mortality in preterm neonatesLink provided by the sponsor.
- Enteral Zinc Supplementation in Preterm or Low Birth Weight Infants: A Systematic Review and Meta-analysisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lauren Walker, DO principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1 mg/day Zinc Supplementation and 3 mg/day Zinc Supplementation in people with Extreme Prematurity,Extremely Low Birthweight and BPD - Bronchopulmonary Dysplasia, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia Newman, DO (706-721-2331, junewman@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Velocity (time frame: Birth to 36 weeks post-menstrual age (PMA) or at discharge from the NICU, whichever occurs first.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.