Zinc Supplementation on Very Low Birth Weight Infant
Primary Purpose
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Zinc Sulfate
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Early-Onset Sepses, Neonatal
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment Group
Control Group
Arm Description
Participants who receive the intervention.
Participants who receive the placebo.
Outcomes
Primary Outcome Measures
Body Weight
Body weight measured by gram
Body Length
Body length measured by centimetres
Head Circumference
Head circumference measured by centimetres
Secondary Outcome Measures
Zinc levels
Determine zinc levels before and after in participants with zinc supplementation and placebo
Rate of mortality
Comparison of mortality rates in participants with zinc supplementation and placebo
Number of participants with side effects
Number of participants with side effects that occur due to zinc supplementation
Number of participants with late-onset sepsis
Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo
Number of participants with intraventricular haemorrhage
Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo
Number of participants with bronchopulmonary dysplasia
Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo
Number of participants with retinopathy of prematurity
Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo
Full Information
NCT ID
NCT04050488
First Posted
July 30, 2019
Last Updated
August 13, 2019
Sponsor
Fakultas Kedokteran Universitas Indonesia
1. Study Identification
Unique Protocol Identification Number
NCT04050488
Brief Title
Zinc Supplementation on Very Low Birth Weight Infant
Official Title
Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2019 (Anticipated)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fakultas Kedokteran Universitas Indonesia
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Early-Onset Sepses, Neonatal, Periventricular Haemorrhage Neonatal, Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Enterocolitis, Necrotizing, Small for Gestational Age Infant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model 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. 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).
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
364 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group
Arm Type
Active Comparator
Arm Description
Participants who receive the intervention.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants who receive the placebo.
Intervention Type
Drug
Intervention Name(s)
Zinc Sulfate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Weight
Description
Body weight measured by gram
Time Frame
8 to 12 weeks
Title
Body Length
Description
Body length measured by centimetres
Time Frame
8 to 12 weeks
Title
Head Circumference
Description
Head circumference measured by centimetres
Time Frame
8 to 12 weeks
Secondary Outcome Measure Information:
Title
Zinc levels
Description
Determine zinc levels before and after in participants with zinc supplementation and placebo
Time Frame
8 to 12 weeks
Title
Rate of mortality
Description
Comparison of mortality rates in participants with zinc supplementation and placebo
Time Frame
8 to 12 weeks
Title
Number of participants with side effects
Description
Number of participants with side effects that occur due to zinc supplementation
Time Frame
8 to 12 weeks
Title
Number of participants with late-onset sepsis
Description
Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo
Time Frame
8 to 12 weeks
Title
Number of participants with intraventricular haemorrhage
Description
Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo
Time Frame
8 to 12 weeks
Title
Number of participants with bronchopulmonary dysplasia
Description
Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo
Time Frame
8 to 12 weeks
Title
Number of participants with retinopathy of prematurity
Description
Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo
Time Frame
8 to 12 weeks
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Risma Ke Kaban, Doctorate
Phone
+62 816 902 051
Email
rismakk@yahoo.co.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henri Azis, Master
Organizational Affiliation
Fakultas Kedokteran Universitas Indonesia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
24025633
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.
Results Reference
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PubMed Identifier
28891027
Citation
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.
Results Reference
background
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Zinc Supplementation on Very Low Birth Weight Infant
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