Clinical trial NCT04050488: Zinc Supplementation on Very Low Birth Weight Infant
Official title: Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Early-Onset Sepses, Neonatal
Periventricular Haemorrhage Neonatal
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Enterocolitis, Necrotizing
Small for Gestational Age Infant
Lead sponsor: Fakultas Kedokteran Universitas Indonesia
Sponsor class: OTHER
First posted: 2019-08-08
Enrollment: 364
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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. There were two research groups, namely the treatment group (the group that received zinc supplementation) and the control group (the group that received the placebo). In both groups the differences in growth indicators (body weight, body length, and head circumference) will be evaluated, the incidence of morbidity (sepsis, necrotizing enterocolitis, retinopathy of prematurity, intraventricular hemorrhage and bronchopulmonary dysplasia).
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Preterm (gestational age of 28 - 32 weeks)
* Newborns with a ratio of body weight and gestational age: Small for Gestational Age or Large for Gestational Age
* Get parental approval to be included in the study by signing an informed consent

Exclusion Criteria:

* Newborns with severe congenital abnormalities
* Newborns with digestive tract abnormalities: partial, total obstruction or gastrointestinal atresia
* Newborns with unstable hemodynamic conditions that will affect the survival rate
* Mothers who consume alcohol regularly (≧ 2x a month) during pregnancy
* Newborns with early-onset sepsis

Primary outcomes:
measure: Body Weight
timeFrame: 8 to 12 weeks
measure: Body Length
timeFrame: 8 to 12 weeks
measure: Head Circumference
timeFrame: 8 to 12 weeks
Secondary outcomes:
measure: Zinc levels
timeFrame: 8 to 12 weeks
measure: Rate of mortality
timeFrame: 8 to 12 weeks
measure: Number of participants with side effects
timeFrame: 8 to 12 weeks
measure: Number of participants with late-onset sepsis
timeFrame: 8 to 12 weeks
measure: Number of participants with intraventricular haemorrhage
timeFrame: 8 to 12 weeks
measure: Number of participants with bronchopulmonary dysplasia
timeFrame: 8 to 12 weeks
measure: Number of participants with retinopathy of prematurity
timeFrame: 8 to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Fakultas Kedokteran Universitas Indonesia
name: Henri Azis, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: Terrin G, Berni Canani R, Passariello A, Messina F, Conti MG, Caoci S, Smaldore A, Bertino E, De Curtis M. Zinc supplementation reduces morbidity and mortality in very-low-birth-weight preterm neonates: a hospital-based randomized, placebo-controlled trial in an industrialized country. Am J Clin Nutr. 2013 Dec;98(6):1468-74. doi: 10.3945/ajcn.112.054478. Epub 2013 Sep 11.
citation: Banupriya N, Bhat BV, Benet BD, Catherine C, Sridhar MG, Parija SC. Short Term Oral Zinc Supplementation among Babies with Neonatal Sepsis for Reducing Mortality and Improving Outcome - A Double-Blind Randomized Controlled Trial. Indian J Pediatr. 2018 Jan;85(1):5-9. doi: 10.1007/s12098-017-2444-8. Epub 2017 Sep 11.