Status:
RECRUITING
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
Lead Sponsor:
Prince of Songkla University
Conditions:
Very Preterm Infants
Zinc Deficiency
Eligibility:
All Genders
Phase:
NA
Brief Summary
The goal of this randomized clinical trial is to compare the effect of higher (10 mg per day) versus standard (1 mg per day) doses of zinc supplementation The main questions it aims to answer are: * ...
Detailed Description
After informed consent, the neonates enrolled were randomly allocated to two study groups: group A (higher dose of zinc sulfate 10 mg/day; each 1 mL contains 10 mg of elemental zinc; Pharmacy Division...
Eligibility Criteria
Inclusion
- Very preterm neonates (gestational age \[GA\]: 24 0/7-32 6/7 weeks and BW: 401-1800 grams) were consecutively admitted in the NICU and NMCU
- Body weight at enrollment less than 800 grams
- Stable neonates and full enteral feeding (150 mL/kg/day) at least for a few days
Exclusion
- Outborn neonate who was admitted in study center after 7 days of life
- Congenital infections
- Malformations, syndromes, or genetic defects
- Evidence of culture proven sepsis or necrotizing enterocolitis or death diagnosed before enrollment
- Gastrointestinal (GI) surgery or high GI fluid output (usually ileostomy losses)
- Unstable neonate during weighing including on intercostal drainage tube or drainage
- Neonates need diuretics more than 7 days
- Severe birth asphyxia (5-minute Apgar score less than 4)
- Parents' decision not to participate the study
Key Trial Info
Start Date :
April 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06219525
Start Date
April 2 2024
End Date
December 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, Thailand, 90110