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Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants

RecruitingNAAges any - anyAllPrince of Songkla University
NCT06219525 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: * Growth velocities and delta z-scores during the date of start intervention until the end of the time interval (at least 2 weeks of intervention on date of 44 weeks of postmenstrual age or discharge whichever came first) in very preterm infants with a birthweight less than1800 grams. * Growth and neurodevelopment at 24 months postnatal age

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Higher dose of enteral zinc
  • Standard dose of enteral zinc
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Where

1 site
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Thailand
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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