Comparing higher and standard doses of zinc for very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effects of higher (10 mg/day) versus standard (1 mg/day) doses of zinc supplementation in very preterm infants with a birth weight of less than 1800 grams. The study involves random allocation of neonates to receive either dose, with the administration of zinc occurring once daily after feeding. The primary outcomes include growth velocities and neurodevelopmental assessments at 24 months postnatal age. The trial is conducted in a blinded manner to ensure unbiased results.

Why it matters

Who can join: the full rules

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

Where it's running

• Songklanagarind Hospital, Prince of Songkla University
  Hat Yai, Changwat Songkhla, Thailand Recruiting

Study contacts

• Principal investigator: Anucha Thatrimontrichai, MD — Prince of Songkla University
• Study coordinator: Anucha Thatrimontrichai, MD
• Email: tanucha@medicine.psu.ac.th
• Phone: +66 954300690

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.