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Zinc Supplementation on Very Low Birth Weight Infant

NCT04050488 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2019-08-15

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    lead OTHER

Principal Investigators

  • Henri Azis, Master · Fakultas Kedokteran Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
3 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2020-07-31
Completion
2020-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04050488 on ClinicalTrials.gov