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Trial record 2 of 4 for:    "Enterocolitis" | "Zinc"

Zinc Supplementation on Very Low Birth Weight Infant

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ClinicalTrials.gov Identifier: NCT04050488
Recruitment Status : Not yet recruiting
First Posted : August 8, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
RismaKK, Fakultas Kedokteran Universitas Indonesia

Tracking Information
First Submitted Date  ICMJE July 30, 2019
First Posted Date  ICMJE August 8, 2019
Last Update Posted Date August 15, 2019
Estimated Study Start Date  ICMJE August 20, 2019
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Body Weight [ Time Frame: 8 to 12 weeks ]
    Body weight measured by gram
  • Body Length [ Time Frame: 8 to 12 weeks ]
    Body length measured by centimetres
  • Head Circumference [ Time Frame: 8 to 12 weeks ]
    Head circumference measured by centimetres
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04050488 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 13, 2019)
  • Zinc levels [ Time Frame: 8 to 12 weeks ]
    Determine zinc levels before and after in participants with zinc supplementation and placebo
  • Rate of mortality [ Time Frame: 8 to 12 weeks ]
    Comparison of mortality rates in participants with zinc supplementation and placebo
  • Number of participants with side effects [ Time Frame: 8 to 12 weeks ]
    Number of participants with side effects that occur due to zinc supplementation
  • Number of participants with late-onset sepsis [ Time Frame: 8 to 12 weeks ]
    Comparison of number of participants with late-onset sepsis with zinc supplementation and placebo
  • Number of participants with intraventricular haemorrhage [ Time Frame: 8 to 12 weeks ]
    Comparison of number of participants with intraventricular haemorrhage with zinc supplementation and placebo
  • Number of participants with bronchopulmonary dysplasia [ Time Frame: 8 to 12 weeks ]
    Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo
  • Number of participants with retinopathy of prematurity [ Time Frame: 8 to 12 weeks ]
    Comparison of number of participantswith retinopathy of prematurity with zinc supplementation and placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Zinc levels [ Time Frame: 8 to 12 weeks ]
    Determine zinc levels in preterm infants
  • Mortality [ Time Frame: 8 to 12 weeks ]
    Mortality in preterm infants
  • Side effects [ Time Frame: 8 to 12 weeks ]
    Side effects that occur due to zinc supplementation
  • Morbidity [ Time Frame: 8 to 12 weeks ]
    Morbidity in preterm infants (existence of sepsis, intraventricular haemorrhage, bronchopulmonary dysplasia, retinopathy of prematurity)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Zinc Supplementation on Very Low Birth Weight Infant
Official Title  ICMJE Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Triple (Participant, Investigator, Outcomes 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.
Primary Purpose: Treatment
Condition  ICMJE
  • Early-Onset Sepses, Neonatal
  • Periventricular Haemorrhage Neonatal
  • Bronchopulmonary Dysplasia
  • Retinopathy of Prematurity
  • Enterocolitis, Necrotizing
  • Small for Gestational Age Infant
Intervention  ICMJE
  • 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.
  • Drug: 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.
Study Arms  ICMJE
  • Active Comparator: Treatment Group
    Participants who receive the intervention.
    Intervention: Drug: Zinc Sulfate
  • Placebo Comparator: Control Group
    Participants who receive the placebo.
    Intervention: Drug: Placebos
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2019)
364
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2020
Estimated Primary Completion Date July 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Risma Ke Kaban, Doctorate +62 816 902 051 rismakk@yahoo.co.uk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04050488
Other Study ID Numbers  ICMJE IKA001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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
Responsible Party RismaKK, Fakultas Kedokteran Universitas Indonesia
Study Sponsor  ICMJE Fakultas Kedokteran Universitas Indonesia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Henri Azis, Master Fakultas Kedokteran Universitas Indonesia
PRS Account Fakultas Kedokteran Universitas Indonesia
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP