Brief Title
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
Official Title
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
Brief 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. 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 Type
Interventional
Primary Outcome
Growth rate for weight (g/kg/day) from birth to 36+0 weeks corrected gestational age (CGA)
Secondary Outcome
Measure changes in serum insulin-like growth factor 1 (IGF-1)
Condition
Infant,Premature
Intervention
Zinc Acetate
Study Arms / Comparison Groups
Zinc plus standard of care
Description: Infants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Dietary Supplement
Estimated Enrollment
126
Start Date
March 22, 2018
Completion Date
June 30, 2021
Primary Completion Date
June 30, 2021
Eligibility Criteria
Inclusion Criteria:
1. 23 0/7 to 29 6/7 weeks GA
2. Birth weight 501 to 1000g, inclusive
3. 14 to 28 days of life, inclusive
4. 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).-
Exclusion Criteria:
1. Major congenital and/or chromosomal anomalies
2. Inability to reach 80ml/kg/day enteral feeds by 28 days of life
Gender
All
Ages
N/A - 28 Days
Accepts Healthy Volunteers
No
Contacts
Maggie Sekhon, MD, 801-587-7499, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03532555
Organization ID
102434
Responsible Party
Principal Investigator
Study Sponsor
University of Utah
Collaborators
Intermountain Research and Medical Foundation
Study Sponsor
Maggie Sekhon, MD, Principal Investigator, University of Utah
Verification Date
October 2019