Bronchopulmonary Dysplasia Clinical Trial
Official title:
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fakultas Kedokteran Universitas Indonesia |
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
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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