Infant,PrematureNCT03532555
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
A study testing Zinc Acetate and No supplemental zinc in people with Infant,Premature and Bronchopulmonary Dysplasia, run by University of Utah at 2 sites in United States.
Trial summary
Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Read more about this study
- Who is it for?
- Ages 14 to 28 days
- Conditions the study is for
- Infant,Premature, Bronchopulmonary Dysplasia, Growth Failure
- What is being tested?
- Zinc Acetate and No supplemental zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Mar 2018to 25 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 23 0/7 to 29 6/7 weeks GA
- Birth weight 501 to 1000g, inclusive
- 14 to 28 days of life, inclusive
- 14 day BPD risk score ≥ 50% for death or moderate-severe BPD, calculated using the algorithm on the Neonatal Research Network website (https://neonatal.rti.org/index.cfm?fuseaction=BPDCalculator.start).-
Who cannot join
- Major congenital and/or chromosomal anomalies
- Inability to reach 80ml/kg/day enteral feeds by 28 days of life
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Medical Center
Murray, Utah, 84107
University of Utah Health
Salt Lake City, Utah, 84112
About this study
Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits manifest as lower weight, length, and head circumference, as well as changes in body composition. These deficits precede the development of BPD and persist post-discharge. While similar rates of growth are observed in very low birth weight infants with and without BPD once receiving equal calories, catch up growth does not occur in the BPD group. Thus, early growth deficits remained uncompensated.
After iron, zinc is the most metabolically active trace element in the human body. It has a critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs in the third trimester. Impaired intake and absorption or excess excretion can further increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase the need for zinc.
Read more
Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However, while zinc depletion is associated with deficiency, the opposite may not be true. For example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding, suggesting overall requirements are related to needs, regardless of overall zinc status. This may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc level. Thus, zinc deficiency should be considered in infants with poor growth despite receiving adequate protein and calories.
The objective of this study is to determine whether enteral zinc supplementation leads to improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's hypothesis is that enteral zinc supplementation in very preterm infants at high risk for BPD will significantly improve growth compared to standard of care.
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Growth Failure
- Being tested
- Zinc Acetate, No supplemental zinc
- Keywords
- zinc
- Medical subject headings
- Premature Birth, Bronchopulmonary Dysplasia, Failure to Thrive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc AcetateDietary supplement
Zinc Acetate given with elemental zinc dose of 2mg/kg given orally only daily through 35 6/7 weeks corrected gestational age
No supplemental zincOther
Infants will receive standard of care, which is currently no supplemental zinc
| Study group | Role | What they receive |
|---|---|---|
| Zinc plus standard of care | Active comparator | Infants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age. Receives: Dietary Supplement: Zinc Acetate |
| Standard of care only | Placebo comparator | Infants will not receive any doses of zinc through 35 6/7 weeks corrected gestational age Receives: Other: No supplemental zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth rate for weight (g/kg/day) from birth to 36+0 weeks corrected gestational age (CGA)
Average daily changes in weight from birth to 36+0 CGA will be calculated and compared between both arms.
Measured: Birth to 36+0 weeks corrected gestational age
Growth rate for weight (g/kg/day) from birth to 40+0 weeks CGA
Average daily changes in weight from birth to 40+0 CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
Measured: Birth to 40+0 weeks corrected gestational age
Growth rate for length (cm/week) from birth to 36+0 weeks CGA
Average weekly changes in length from birth to 36+0 weeks CGA will be calculated and compared between both arms.
Measured: Birth to 36+0 weeks corrected gestational age
Growth rate for length (cm/week) from birth to 40+0 weeks CGA
Average weekly changes in length from birth to 40+0 weeks (or discharge, whichever happens first) CGA will be calculated and compared between both arms.
Measured: Birth to 40+0 weeks corrected gestational age
Growth rate for head circumference (cm/week) from birth to 36+0 weeks CGA
Average weekly changes in head circumference from birth to 36+0 weeks CGA will be calculated and compared between both arms.
Measured: Birth to 36+0 weeks corrected gestational age
Growth rate for head circumference (cm/week) from birth to 40+0 weeks CGA
Average weekly changes in head circumference from birth to 40+0 weeks CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
Measured: Birth to 40+0 weeks corrected gestational age
Secondary outcomes (4)
Measure changes in serum insulin-like growth factor 1 (IGF-1)
Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms
Measured: Study day 0 to 36 weeks corrected gestational age
Measure changes in serum insulin-like growth factor binding protein 3 (IGFBP-3)
Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms
Measured: Study day 0 to 36 weeks corrected gestational age
Measure rates of severe BPD diagnoses at 36+0 weeks CGA
Infants will be screened per the NICHD 2001 criteria for severe BPD at 36+0 weeks CGA and these rates will be compared between the two arms.
Measured: 36+0 weeks corrected gestational age
Measure changes in bone quality per tibial ultrasound
Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms
Measured: Study day 0 to 36 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start22 Mar 2018
- Primary completion25 May 2022
- Study completion25 Aug 2022
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant,PrematureStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Infants will be stratified by gestational age (23-24 wks, 25-26 wks, 27-29 wks) and then are randomized to receive supplemental oral zinc acetate or no zinc acetate.
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Responsible party
- Principal investigator, Bradley Yoder, University of Utah
- Investigators
- Bradley Yoder, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03532555
- Sponsor's protocol ID
- 102434
- Status last verified
- Jan 2022
- First submitted
- 24 Apr 2018
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Staub E, Evers K, Askie LM. Enteral zinc supplementation for prevention of morbidity and mortality in preterm neonates. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD012797. doi: 10.1002/14651858.CD012797.pub2.
PubMed 33710626Vazquez-Gomis R, Bosch-Gimenez V, Juste-Ruiz M, Vazquez-Gomis C, Izquierdo-Fos I, Pastor-Rosado J. Zinc concentration in preterm newborns at term age, a prospective observational study. BMJ Paediatr Open. 2019 Sep 13;3(1):e000527. doi: 10.1136/bmjpo-2019-000527. eCollection 2019.
PubMed 31646195
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT03532555
- Acronym / sponsor ID
- 102434
- Conditions
- Infant,Premature, Bronchopulmonary Dysplasia, Growth Failure
- Keywords
- zinc
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 22 May 2018 (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.
Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits manifest as lower weight, length, and head circumference, as well as changes in body composition. These deficits precede the development of BPD and persist post-discharge. While similar rates of growth are observed in very low birth weight infants with and without BPD once receiving equal calories, catch up growth does not occur in the BPD group. Thus, early growth deficits remained uncompensated.
After iron, zinc is the most metabolically active trace element in the human body. It has a critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs in the third trimester. Impaired intake and absorption or excess excretion can further increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase the need for zinc.
Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However, while zinc depletion is associated with deficiency, the opposite may not be true. For example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding, suggesting overall requirements are related to needs, regardless of overall zinc status. This may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc level. Thus, zinc deficiency should be considered in infants with poor growth despite receiving adequate protein and calories.
The objective of this study is to determine whether enteral zinc supplementation leads to improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's hypothesis is that enteral zinc supplementation in very preterm infants at high risk for BPD will significantly improve growth compared to standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infants will be stratified by gestational age (23-24 wks, 25-26 wks, 27-29 wks) and then are randomized to receive supplemental oral zinc acetate or no zinc acetate.
| Arm | Type | Receives |
|---|---|---|
| Zinc plus standard of care | Active comparator | Dietary Supplement: Zinc AcetateInfants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age. |
| Standard of care only | Placebo comparator | Other: No supplemental zincInfants will not receive any doses of zinc through 35 6/7 weeks corrected gestational age |
Who may qualify
- Ages
- 14 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 23 0/7 to 29 6/7 weeks GA
- Birth weight 501 to 1000g, inclusive
- 14 to 28 days of life, inclusive
- 14 day BPD risk score ≥ 50% for death or moderate-severe BPD, calculated using the algorithm on the Neonatal Research Network website (https://neonatal.rti.org/index.cfm?fuseaction=BPDCalculator.start).-
Key exclusion criteria (2 listed)
- Major congenital and/or chromosomal anomalies
- Inability to reach 80ml/kg/day enteral feeds by 28 days of life
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 |
|---|---|---|
| Zinc AcetateZinc Acetate given with elemental zinc dose of 2mg/kg given orally only daily through 35 6/7 weeks corrected gestational age | Dietary supplement | Zinc plus standard of care |
| No supplemental zincInfants will receive standard of care, which is currently no supplemental zinc | Other | Standard of care only |
Primary outcome
Growth rate for weight (g/kg/day) from birth to 36+0 weeks corrected gestational age (CGA)
Time frame: Birth to 36+0 weeks corrected gestational age
Average daily changes in weight from birth to 36+0 CGA will be calculated and compared between both arms.
Growth rate for weight (g/kg/day) from birth to 40+0 weeks CGA
Time frame: Birth to 40+0 weeks corrected gestational age
Average daily changes in weight from birth to 40+0 CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
Growth rate for length (cm/week) from birth to 36+0 weeks CGA
Time frame: Birth to 36+0 weeks corrected gestational age
Average weekly changes in length from birth to 36+0 weeks CGA will be calculated and compared between both arms.
Growth rate for length (cm/week) from birth to 40+0 weeks CGA
Time frame: Birth to 40+0 weeks corrected gestational age
Average weekly changes in length from birth to 40+0 weeks (or discharge, whichever happens first) CGA will be calculated and compared between both arms.
Growth rate for head circumference (cm/week) from birth to 36+0 weeks CGA
Time frame: Birth to 36+0 weeks corrected gestational age
Average weekly changes in head circumference from birth to 36+0 weeks CGA will be calculated and compared between both arms.
Growth rate for head circumference (cm/week) from birth to 40+0 weeks CGA
Time frame: Birth to 40+0 weeks corrected gestational age
Average weekly changes in head circumference from birth to 40+0 weeks CGA (or discharge, whichever happens first) will be calculated and compared between both arms.
4 secondary outcomes
Measure changes in serum insulin-like growth factor 1 (IGF-1)
Time frame: Study day 0 to 36 weeks corrected gestational age
Measure changes in serum insulin-like growth factor binding protein 3 (IGFBP-3)
Time frame: Study day 0 to 36 weeks corrected gestational age
Measure rates of severe BPD diagnoses at 36+0 weeks CGA
Time frame: 36+0 weeks corrected gestational age
Measure changes in bone quality per tibial ultrasound
Time frame: Study day 0 to 36 weeks corrected gestational age
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Derived from this study: PubMed 33710626Staub E, Evers K, Askie LM. Enteral zinc supplementation for prevention of morbidity and mortality in preterm neonates. Cochrane Database Syst Rev. 2021 Mar 12;3(3):CD012797. doi: 10.1002/14651858.CD012797.pub2.
- Derived from this study: PubMed 31646195Vazquez-Gomis R, Bosch-Gimenez V, Juste-Ruiz M, Vazquez-Gomis C, Izquierdo-Fos I, Pastor-Rosado J. Zinc concentration in preterm newborns at term age, a prospective observational study. BMJ Paediatr Open. 2019 Sep 13;3(1):e000527. doi: 10.1136/bmjpo-2019-000527. eCollection 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bradley Yoder, MD principal investigator
University of Utah
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Acetate and No supplemental zinc in people with Infant,Premature and Bronchopulmonary Dysplasia, run by University of Utah at 2 sites 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth rate for weight (g/kg/day) from birth to 36+0 weeks corrected gestational age (CGA) (time frame: Birth to 36+0 weeks corrected gestational age). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03532555, which also lists 2 linked publications.
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 9 May 2023.