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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04050488
Other study ID # IKA001
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date August 20, 2019
Est. completion date July 31, 2020

Study information

Verified date August 2019
Source Fakultas Kedokteran Universitas Indonesia
Contact Risma Ke Kaban, Doctorate
Phone +62 816 902 051
Email rismakk@yahoo.co.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 364
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 3 Days
Eligibility 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 Design


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.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Fakultas Kedokteran Universitas Indonesia

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Body Weight Body weight measured by gram 8 to 12 weeks
Primary Body Length Body length measured by centimetres 8 to 12 weeks
Primary Head Circumference Head circumference measured by centimetres 8 to 12 weeks
Secondary Zinc levels Determine zinc levels before and after in participants with zinc supplementation and placebo 8 to 12 weeks
Secondary Rate of mortality Comparison of mortality rates in participants with zinc supplementation and placebo 8 to 12 weeks
Secondary Number of participants with side effects Number of participants with side effects that occur due to zinc supplementation 8 to 12 weeks
Secondary 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
Secondary Number of participants with intraventricular haemorrhage Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo 8 to 12 weeks
Secondary Number of participants with bronchopulmonary dysplasia Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo 8 to 12 weeks
Secondary Number of participants with retinopathy of prematurity Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo 8 to 12 weeks
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