Higher and Standard Doses of Enteral Zinc Supplementation in Very Preterm Infants

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

April 2, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2027

Conditions
Very Preterm InfantsZinc Deficiency
Interventions
DIETARY_SUPPLEMENT

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). 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.

DIETARY_SUPPLEMENT

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). 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.

Trial Locations (1)

90110

RECRUITING

Songklanagarind Hospital, Prince of Songkla University, Hat Yai

All Listed Sponsors
lead

Prince of Songkla University

OTHER