Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants: A Randomized Controlled Trial
Prince of Songkla University
120 participants
Apr 2, 2024
INTERVENTIONAL
Conditions
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: * 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
Eligibility
Inclusion Criteria3
- 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 Criteria9
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Higher dose of zinc sulfate 10 mg/day; each 1 mL contains 10 mg of elemental zinc (osmolality 450 Osm/kg H2O). After randomization, nurses blinded to the study aims administered the assigned preparation 1 mL via tuberculin syringe, once daily, 1 hour after feeding. Zinc sulphate oral solution was prepared by the pharmaceutical compounding unit in the hospital. The supplement was given again to subjects who vomited within 15 minutes after the administration. All episodes of vomiting were reported on the record form. Vomiting episodes within 15 minutes were recorded. The supplement assigned was at discharge or at 44 weeks of postmenstrual age whichever came first. Both groups received multivitamin (MTV) products and iron supplement as routine preterm care.
Standard dose of zinc sulfate 1 mg/day; each 1 mL contains 1 mg of elemental zinc (osmolality 45 Osm/kg H2O). After randomization, nurses blinded to the study aims administered the assigned preparation 1 mL via tuberculin syringe, once daily, 1 hour after feeding. Zinc sulphate oral solution was prepared by the pharmaceutical compounding unit in the hospital. The supplement was given again to subjects who vomited within 15 minutes after the administration. All episodes of vomiting were reported on the record form. Vomiting episodes within 15 minutes were recorded. The supplement assigned was discontinued at discharge or at 44 weeks of postmenstrual age whichever came first. Both groups received multivitamin (MTV) products and iron supplement as routine preterm care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06219525