Bronchopulmonary Dysplasia Clinical Trial
Official title:
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia
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.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04506619 -
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
|
||
Completed |
NCT04936477 -
Ventilation-perfusion (V/Q) Ratio and Alveolar Surface Area in Preterm Infants
|
N/A | |
Recruiting |
NCT05285345 -
Implementation of a Consensus-Based Discharge Protocol for Preterm Infants With Lung Disease
|
||
Completed |
NCT03649932 -
Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing
|
Phase 1 | |
Terminated |
NCT02524249 -
Early Versus Late Caffeine for ELBW Newborns
|
N/A | |
Completed |
NCT02249143 -
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants
|
N/A | |
Active, not recruiting |
NCT01632475 -
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
|
||
Completed |
NCT01460576 -
Improving Prematurity-Related Respiratory Outcomes at Vanderbilt
|
N/A | |
Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
Completed |
NCT00419588 -
Growth of Airways and Lung Tissues in Premature and Healthy Infants
|
||
Completed |
NCT00319956 -
Trial II of Lung Protection With Azithromycin in the Preterm Infant
|
Phase 2 | |
Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
Completed |
NCT00006401 -
Inhaled Nitric Oxide for Preventing Chronic Lung Disease in Premature Infants
|
Phase 3 | |
Terminated |
NCT05030012 -
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
|
N/A | |
Completed |
NCT00006058 -
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|
N/A | |
Completed |
NCT00005376 -
Premature Birth and Its Sequelae in Women
|
N/A | |
Completed |
NCT00011362 -
Dexamethasone Therapy in VLBW Infants at Risk of CLD
|
Phase 3 | |
Completed |
NCT00004805 -
Study of the Effect of Four Methods of Cardiopulmonary Resuscitation Instruction on Psychosocial Response of Parents With Infants at Risk of Sudden Death
|
N/A | |
Completed |
NCT05152316 -
The Baby Lung Study
|
||
Recruiting |
NCT04821453 -
NAVA vs. CMV Crossover in Severe BPD
|
N/A |