Zinc Supplementation on Very Low Birth Weight Infant

NCT04050488 | Unknown Phase 4 DMC

• 1 other identifier: IKA001
• Study Type: interventional
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Zinc levels

  8 to 12 weeks

• Rate of mortality

  8 to 12 weeks

• Number of participants with side effects

  8 to 12 weeks

• Number of participants with late-onset sepsis

  8 to 12 weeks

• Number of participants with intraventricular haemorrhage

  8 to 12 weeks

Study Arms (2)

Treatment Group

ACTIVE COMPARATOR

Participants who receive the intervention.

Drug: Zinc Sulfate

Control Group

PLACEBO COMPARATOR

Participants who receive the placebo.

Drug: Placebos

Interventions

Zinc Sulfate DRUG

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.

Treatment Group

Placebos DRUG

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.

Control Group

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fakultas Kedokteran Universitas Indonesia: lead

Related Publications (2)

• 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.

  PMID: 24025633 BACKGROUND

• 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.

  PMID: 28891027 BACKGROUND

MeSH Terms

Conditions

Neonatal Sepsis; Bronchopulmonary Dysplasia; Retinopathy of Prematurity; Enterocolitis, Necrotizing

Interventions

Zinc Sulfate

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Retinal Diseases; Eye Diseases; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Henri Azis, Master

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Risma Ke Kaban, Doctorate

CONTACT

+62 816 902 051; rismakk@yahoo.co.uk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is carried out by research assistants, then making sequential numbers with closed envelopes that have been prepared. The results of the randomization are only known by research assistants. At the age of 3 days or priming\> 20cc / kg body weight/day, the research assistant will give a bottle of medicine containing zinc/placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse. The researcher monitors all patients who are sampled without knowing which group is the test and which group is the control.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 8, 2019
• Study Start: August 20, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share