Comparing higher and standard doses of zinc for very preterm infants
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants: A Randomized Controlled Trial
This study tests if giving very preterm infants a higher dose of zinc can help them grow better and develop more normally compared to a standard dose.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Prince of Songkla University Academic / other |
| Locations | 1 site (Hat Yai, Changwat Songkhla) |
| Trial ID | NCT06219525 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are very preterm neonates born between 24 and 32 weeks of gestation with a body weight less than 800 grams.
Not a fit: Patients who may not benefit from this study include those with congenital infections, severe birth asphyxia, or other significant health complications.
Why it matters
Potential benefit: If successful, this study could improve growth and neurodevelopment outcomes in very preterm infants suffering from zinc deficiency.
How similar studies have performed: Other studies have shown promising results with zinc supplementation in preterm infants, indicating potential benefits in growth and development.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hat Yai, Changwat Songkhla
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.