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

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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