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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
Fakultas Kedokteran Universitas Indonesia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Early-Onset Sepses, Neonatal

Eligibility Criteria

undefined - 3 Days (Child)All SexesAccepts Healthy Volunteers

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

    First Posted
    July 30, 2019
    Last Updated
    August 13, 2019
    Sponsor
    Fakultas Kedokteran Universitas Indonesia
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    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
    background
    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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