An interventional study of Zinc Acetate and No supplemental zinc in Infant,Premature, Bronchopulmonary Dysplasia and Growth Failure, sponsored by University of Utah. Terminated at 2 sites in United States. Open to participants aged 14 Days to 28 Days. Per ClinicalTrials.gov, last updated 2023-05-09.
Sponsored by University of Utah · Not applicable, Interventional, and Treatment
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.
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This study's enrollment of 37 is below the median of 84 across 1,666 interventional studies indexed under Premature Birth.
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Exclusion Criteria:
Infants will receive daily doses of zinc at 2mg/kg from enrollment through 35 6/7 weeks corrected gestational age.
Dietary Supplement: Zinc Acetate
Infants will not receive any doses of zinc through 35 6/7 weeks corrected gestational age
Other: No supplemental zinc
Zinc Acetate given with elemental zinc dose of 2mg/kg given orally only daily through 35 6/7 weeks corrected gestational age
Infants will receive standard of care, which is currently no supplemental zinc
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Birth to 40+0 weeks corrected gestational age
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Study day 0 to 36 weeks corrected gestational age
Plan to share: No
Ran from Mar 2018 to primary completion in May 2022, 50 months.
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This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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