Zinc Supplementation on Very Low Birth Weight Infant

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.

Study Overview

• Status: Unknown
• Conditions: Enterocolitis, Necrotizing; Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Early-Onset Sepses, Neonatal; Small for Gestational Age Infant; Periventricular Haemorrhage Neonatal
• Intervention / Treatment: Drug: Zinc Sulfate; Drug: Placebos

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.

• Study Type: Interventional
• Enrollment (Anticipated): 364
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Risma Ke Kaban, Doctorate; Phone Number: +62 816 902 051; Email: rismakk@yahoo.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment Group; Participants who receive the intervention.	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.
Placebo Comparator: Control Group; Participants who receive the placebo.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Body weight measured by gram	8 to 12 weeks
Body Length	Body length measured by centimetres	8 to 12 weeks
Head Circumference	Head circumference measured by centimetres	8 to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Zinc levels	Determine zinc levels before and after in participants with zinc supplementation and placebo	8 to 12 weeks
Rate of mortality	Comparison of mortality rates in participants with zinc supplementation and placebo	8 to 12 weeks
Number of participants with side effects	Number of participants with side effects that occur due to zinc supplementation	8 to 12 weeks
Number of participants with late-onset sepsis	Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo	8 to 12 weeks
Number of participants with intraventricular haemorrhage	Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo	8 to 12 weeks
Number of participants with bronchopulmonary dysplasia	Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo	8 to 12 weeks
Number of participants with retinopathy of prematurity	Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo	8 to 12 weeks

Collaborators and Investigators

• Sponsor: Fakultas Kedokteran Universitas Indonesia
• Investigators: Principal Investigator: Henri Azis, Master, Fakultas Kedokteran Universitas Indonesia

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 20, 2019
• Primary Completion (Anticipated): July 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Respiratory Tract Diseases; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Eye Diseases; Gastrointestinal Diseases; Infant, Newborn, Diseases; Retinal Diseases; Body Weight; Gastroenteritis; Intestinal Diseases; Sepsis; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Hemorrhage; Birth Weight; Enterocolitis; Enterocolitis, Necrotizing; Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Neonatal Sepsis; Physiological Effects of Drugs; Dermatologic Agents; Astringents; Zinc Sulfate
• Other Study ID Numbers: IKA001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: This research can be done in other places by considering the condition of existing medical servants. When giving a good outcome, you can contact the research contact

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No