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



Status:Recruiting
Conditions:Bronchitis
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/20/2019
Start Date:March 22, 2018
End Date:June 30, 2020
Contact:Maggie Sekhon, MD
Email:maggie.sekhon@hsc.utah.edu
Phone:801-587-7499

Use our guide to learn which trials are right for you!

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.


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
We found this trial at
2
sites
50 North Medical Drive
Salt Lake City, Utah 84132
Principal Investigator: Maggie Sekhon, MD
Phone: 801-587-7499
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
?
mi
from
Murray, UT
Click here to add this to my saved trials