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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

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.


Condition or disease Intervention/treatment Phase
Early-Onset Sepses, Neonatal Periventricular Haemorrhage Neonatal Bronchopulmonary Dysplasia Retinopathy of Prematurity Enterocolitis, Necrotizing Small for Gestational Age Infant Drug: Zinc Sulfate Drug: Placebos Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
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
Official Title: Oral Zinc Supplementation Improving Growth and Reducing Morbidity on Very Low Birth Weight Infant
Estimated Study Start Date : August 20, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020


Arm Intervention/treatment
Active Comparator: Treatment Group
Participants who receive the 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.

Placebo Comparator: Control Group
Participants who receive the placebo.
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.




Primary Outcome Measures :
  1. Body Weight [ Time Frame: 8 to 12 weeks ]
    Body weight measured by gram

  2. Body Length [ Time Frame: 8 to 12 weeks ]
    Body length measured by centimetres

  3. Head Circumference [ Time Frame: 8 to 12 weeks ]
    Head circumference measured by centimetres


Secondary Outcome Measures :
  1. Zinc levels [ Time Frame: 8 to 12 weeks ]
    Determine zinc levels before and after in participants with zinc supplementation and placebo

  2. Rate of mortality [ Time Frame: 8 to 12 weeks ]
    Comparison of mortality rates in participants with zinc supplementation and placebo

  3. Number of participants with side effects [ Time Frame: 8 to 12 weeks ]
    Number of participants with side effects that occur due to zinc supplementation

  4. 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

  5. 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

  6. Number of participants with bronchopulmonary dysplasia [ Time Frame: 8 to 12 weeks ]
    Comparison of number of participantswith bronchopulmonary dysplasia with zinc supplementation and placebo

  7. 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



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050488


Contacts
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Contact: Risma Ke Kaban, Doctorate +62 816 902 051 rismakk@yahoo.co.uk

Sponsors and Collaborators
Fakultas Kedokteran Universitas Indonesia
Investigators
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Principal Investigator: Henri Azis, Master Fakultas Kedokteran Universitas Indonesia

Publications:
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Responsible Party: RismaKK, Principal Investigator, Fakultas Kedokteran Universitas Indonesia
ClinicalTrials.gov Identifier: NCT04050488     History of Changes
Other Study ID Numbers: IKA001
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
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

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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
Additional relevant MeSH terms:
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Enterocolitis
Enterocolitis, Necrotizing
Zinc
Zinc Sulfate
Neonatal Sepsis
Bronchopulmonary Dysplasia
Retinopathy of Prematurity
Hemorrhage
Birth Weight
Pathologic Processes
Retinal Diseases
Eye Diseases
Body Weight
Signs and Symptoms
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Trace Elements
Micronutrients