Zinc Supplementation on Very Low Birth Weight Infant

University of Indonesia (UI)

Status and phase: Unknown; Phase 4

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

Treatments: Drug: Zinc Sulfate; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT04050488

IKA001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 364 estimated patients

Sex: All

Ages: Under 3 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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364 participants in 2 patient groups, including a placebo group

Treatment Group

Active Comparator group

Description:

Participants who receive the intervention.

Treatment:

Drug: Zinc Sulfate

Control Group

Placebo Comparator group

Description:

Participants who receive the placebo.

Treatment:

Drug: Placebos