Bronchopulmonary Dysplasia Clinical Trial
Official title:
Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
Premature birth is a major cause of neonatal death in addition to neonatal asphyxia and
infections.
Early in life, premature babies must get aggressive nutrition so that there is no
extrauterine growth restriction (EUGR) in the Intrauterine Growth Restriction (IUGR) group
compared to the non-IUGR group.
Other factors that also play a role are long episodes of fasting, the fulfillment of
nutrition (macro and micronutrients) from the start, time to start breastfeeding (ASI),
duration of parenteral total administration, the incidence of respiratory distress syndrome
and incidence of necrotizing enterocolitis.
Zinc is one of the micronutrients which is very risky for deficiency in premature babies.
Babies with zinc deficiency experience growth disorders as much as 67%. In India, infants who
received zinc supplementation increased after being given 10 days of zinc supplementation and
lower mortality rates in the group with supplementation. Very low birth weight babies and
bronchopulmonary dysplasia who received zinc supplementation during the week showed good
clinical progress and the growth rate also increased.
The investigators believe this study has the potential for decreasing infant mortality from
its current level and can be a growth indicator for preterm babies.
Double-blind randomized controlled clinical trial in preterm infants (28 - 32 weeks) who are
newborn or less than 3 days old who are admitted to the perinatology room.
Infant in the intervention group was given elemental zinc supplementation once daily orally
compared to placebo in the control group, at 3 days of age until the patient returned home or
a maximum of 40 weeks' gestation.
The intervention group was given 10 mg elemental zinc once daily orally compared to placebo
in the control group, at 3 days of age and received oral nutrition> 20cc / kg/ day, continued
during treatment until the patient returned home or a maximum of 40 weeks' gestation.
Monitored infant development indicators, measured once a week. Monitoring of the incidence of
infection in late-onset infants in clinical and laboratory settings according to the existing
hospital settings.
The monitoring of NEC events in all research subjects was carried out. Screening ROP at the
age of 3 weeks and/or when the baby is going home. The participants were observed to be
allowed to go home or a maximum of 40 weeks' gestation if they were still being treated.
;
| 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 | |
| Completed |
NCT00419588 -
Growth of Airways and Lung Tissues in Premature and Healthy Infants
|
||
| Unknown status |
NCT00254176 -
Cysteine Supplementation in Critically Ill Neonates
|
Phase 2/Phase 3 | |
| Completed |
NCT00208039 -
Pilot Trial of Surfactant Booster Prophylaxis For Ventilated Preterm Neonates
|
N/A | |
| Completed |
NCT00319956 -
Trial II of Lung Protection With Azithromycin in the Preterm Infant
|
Phase 2 | |
| 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 |