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Trace Element

Zinc plus standard of care for Bronchopulmonary Dysplasia

N/A

Waitlist Available

Led By Bradley Yoder, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth to 40+0 weeks corrected gestational age

Awards & highlights

Study Summary

This trial enrolls very preterm infants who are at high risk for developing BPD. The infants are randomized to receive either enteral zinc supplementation or standard of care. The primary outcome measure is weight at 36 weeks postmenstrual age. Secondary outcome measures include length, head circumference, and body composition.

Eligible Conditions

Bronchopulmonary Dysplasia
Premature Infants
Growth Delay

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth to 40+0 weeks corrected gestational age

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth to 40+0 weeks corrected gestational age

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 40+0 weeks corrected gestational age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Growth rate for head circumference (cm/week) from birth to 36+0 weeks CGA

Growth rate for head circumference (cm/week) from birth to 40+0 weeks CGA

Growth rate for length (cm/week) from birth to 36+0 weeks CGA

+3 more

Secondary outcome measures

Measure changes in bone quality per tibial ultrasound

Measure changes in serum insulin-like growth factor 1 (IGF-1)

Measure changes in serum insulin-like growth factor binding protein 3 (IGFBP-3)

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Zinc plus standard of careActive Control1 Intervention

Infants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age.

Group II: Standard of care onlyPlacebo Group1 Intervention

Infants will not receive any doses of zinc through 35 6/7 weeks corrected gestational age

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of UtahLead Sponsor

1,098 Previous Clinical Trials

1,778,593 Total Patients Enrolled

4 Trials studying Bronchopulmonary Dysplasia

79 Patients Enrolled for Bronchopulmonary Dysplasia

Intermountain Research and Medical FoundationOTHER

5 Previous Clinical Trials

352 Total Patients Enrolled

Bradley Yoder, MDPrincipal Investigator - University of Utah

Alta View Hospital, Intermountain Medical Center, University Of Utah Acuity Care Services, University Of Utah Adult Services, University Of Utah Behavioral Health Services, University Of Utah Specialty Services, University Of Utah Surgical Services

7 Previous Clinical Trials

84,413 Total Patients Enrolled

3 Trials studying Bronchopulmonary Dysplasia

3,635 Patients Enrolled for Bronchopulmonary Dysplasia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently accepted into this research program?

"Affirmative. According to information hosted on clinicaltrials.gov, this research is still recruiting participants and was initially posted in March of 2018 with the latest update being January 3rd 2022. 126 individuals are required between two different medical centres."

Answered by AI

Are people of advanced age excluded from this experiment?

"This clinical trial's inclusion criteria specifies that the youngest participant must be 14 days old, and the oldest cannot exceed 28 days."

Answered by AI

What is the ultimate aim of this trial?

"The principal aim of this investigation is to measure the Developmental Velocity of head circumference (cm/week) from birth until 40+0 weeks CGA. Other outputs that will be monitored include fluctuations in serum IGFBP-3, bone quality as per tibial ultrasound analysis and changes in serum IGF-1 - all at baseline, 28 days after study commencement and 36 weeks CGA for either arm."

Answered by AI

Who would be an eligible candidate for this clinical experiment?

"This medical study is seeking 126 subjects who suffer from bronchopulmonary dysplasia and are between two weeks and four weeks of age."

Answered by AI

Is the enrollment period still open for this experiment?

"The most recent information from clinicaltrials.gov indicates that this medical study is currently recruiting patients. It was initially made available on March 22nd 2018 and the latest update came on January 3rd 2022."

Answered by AI

Recent research and studies

BMJ Paediatrics OpenJournal

Zinc Concentration in Preterm Newborns at Term Age, a Prospective Observational Study

Vázquez-Gomis, Rosmari, Vicente Bosch-Gimenez, Mercedes Juste-Ruiz, Consuelo Vázquez-Gomis, Ignacio Izquierdo-Fos, and José Pastor-Rosado. 2019. “Zinc Concentration in Preterm Newborns at Term Age, a Prospective Observational Study”. BMJ Paediatrics Open. BMJ. doi:10.1136/bmjpo-2019-000527.

clinicaltrials.govStudy

Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia

Bradley Yoder 2018. "Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03532555.