Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorPrince of Songkla University
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Higher dose of enteral zinc
- Standard dose of enteral zinc
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov