NCT04050488

Zinc Supplementation on Very Low Birth Weight Infant

Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (estimated)
• Sponsor: Fakultas Kedokteran Universitas Indonesia · Academic / Other
• Sex: All
• Age: 3 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Early-Onset Sepses, Neonatal
• Periventricular Haemorrhage Neonatal
• Bronchopulmonary Dysplasia
• Retinopathy of Prematurity
• Enterocolitis, Necrotizing
• Small for Gestational Age Infant

Interventions

Type	Name	Description
DRUG	Zinc Sulfate	At the age of 3 days or priming\> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing zinc (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.
DRUG	Placebos	At the age of 3 days or priming\> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.

Timeline

• Start date: 2019-08-20
• Primary completion: 2020-07-31
• Completion: 2020-07-31
• First posted: 2019-08-08
• Last updated: 2019-08-15