Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532555
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : November 5, 2019
Sponsor:
Collaborator:
Intermountain Research and Medical Foundation
Information provided by (Responsible Party):
Bradley Yoder, University of Utah

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.


Condition or disease Intervention/treatment Phase
Infant,Premature Bronchopulmonary Dysplasia Growth Failure Dietary Supplement: Zinc Acetate Other: No supplemental zinc Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Zinc plus standard of care
Infants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age.
Dietary Supplement: Zinc Acetate
Zinc Acetate given with elemental zinc dose of 2mg/kg given orally only daily through 35 6/7 weeks corrected gestational age

Placebo Comparator: Standard of care only
Infants will not receive any doses of zinc through 35 6/7 weeks corrected gestational age
Other: No supplemental zinc
Infants will receive standard of care, which is currently no supplemental zinc




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. Measure changes in serum insulin-like growth factor 1 (IGF-1) [ Time Frame: Study day 0 to 36 weeks corrected gestational age ]
    Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms

  2. Measure changes in serum insulin-like growth factor binding protein 3 (IGFBP-3) [ Time Frame: Study day 0 to 36 weeks corrected gestational age ]
    Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms

  3. Measure rates of severe BPD diagnoses at 36+0 weeks CGA [ Time Frame: 36+0 weeks corrected gestational age ]
    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.

  4. Measure changes in bone quality per tibial ultrasound [ Time Frame: Study day 0 to 36 weeks corrected gestational age ]
    Differences in baseline, 28 days after study intervention initiation, and 36 weeks CGA will be compared between both arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532555


Contacts
Layout table for location contacts
Contact: Maggie Sekhon, MD 801-587-7499 maggie.sekhon@hsc.utah.edu
Contact: Carrie Rau, RN 801-213-3360 carrie.rau@hsc.utah.edu

Locations
Layout table for location information
United States, Utah
Intermountain Medical Center Not yet recruiting
Murray, Utah, United States, 84107
Contact: Bradley Yoder, MD       bradley.yoder@hsc.utah.edu   
University of Utah Health Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Maggie Sekhon, MD    801-587-7499    maggie.sekhon@hsc.utah.edu   
Contact: Carrie Rau, RN    801-213-3360      
Principal Investigator: Maggie Sekhon, MD         
Sub-Investigator: Bradley Yoder, MD         
Sponsors and Collaborators
University of Utah
Intermountain Research and Medical Foundation
Investigators
Layout table for investigator information
Principal Investigator: Maggie Sekhon, MD University of Utah

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bradley Yoder, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT03532555     History of Changes
Other Study ID Numbers: 102434
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bradley Yoder, University of Utah:
zinc
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchopulmonary Dysplasia
Failure to Thrive
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs