Status:
COMPLETED
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial
Lead Sponsor:
Zekai Tahir Burak Women's Health Research and Education Hospital
Collaborating Sponsors:
Ankara City Hospital Bilkent
Conditions:
Preterm Infant
Effect of Drugs
Eligibility:
All Genders
7-9 years
Phase:
PHASE4
Brief Summary
* Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. * Due to many reasons, preterm infants are gene...
Detailed Description
Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigat...
Eligibility Criteria
Inclusion
- \< 32 weeks gestational age and/or \<1500 gr birth weight
- Born in the study hospital
- Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient
Exclusion
- Major congenital malformations and/or critical congenital heart defects
- Born in another hospital
- Severe birth asphyxia
- Severe sepsis
- Previous early-onset NEC history
- Infants on the intervention arm who did not continue Zinc supplementation during the study period
- Hemodynamically unstability
- Infants nil per os
- No consent from the family
- Death before the 7th day of life
Key Trial Info
Start Date :
March 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2015
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT05311540
Start Date
March 14 2014
End Date
April 20 2015
Last Update
February 8 2023
Active Locations (1)
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1
Izmir Democracy University Faculty of Medicine
Izmir, Turkey (Türkiye), 35290