Zinc Supplementation on Very Low Birth Weight Infant

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04050488
• Other study ID #: IKA001
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

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

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