Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants: A Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Thailand
Songklanagarind Hospital, Prince of Songkla University
RECRUITING
Hat Yai
Contact Information
Primary
Anucha Thatrimontrichai, MD
tanucha@medicine.psu.ac.th
+66 954300690
Backup
Boonwiroj Jitwilertrat, MD
Boonwiroj@gmail.com
+66 914953851
Time Frame
Start Date: 2024-04-02
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Higher dose of enteral zinc
higher dose of zinc sulfate 10 mg/day; each 1 mL contains 10 mg of elemental zinc (osmolality 450 Osm/kg H2O).
Placebo_comparator: Standard dose of enteral zinc
standard dose of zinc sulfate 1 mg/day; each 1 mL contains 1 mg of elemental zinc (osmolality 45 Osm/kg H2O).
Related Therapeutic Areas
Sponsors
Leads: Prince of Songkla University

This content was sourced from clinicaltrials.gov