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

Launched by PRINCE OF SONGKLA UNIVERSITY · Jan 12, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how two different doses of zinc supplements affect very preterm infants, who are babies born before 32 weeks of pregnancy and weigh less than 1800 grams. The researchers want to find out if a higher dose of zinc (10 mg per day) helps these babies grow better compared to a standard dose (1 mg per day). They will measure the babies' growth and development up to 24 months of age to see which dose is more beneficial.

To participate in this study, infants must be very preterm, born between 24 to 32 weeks of pregnancy, and weigh less than 800 grams when enrolled. They should also be stable and able to receive full feeding. However, infants with certain health issues, like infections or severe birth complications, will not be eligible. Parents of participating infants can expect to be closely monitored during the study, which will last at least two weeks. This research could provide important information on how to support the health and development of very preterm babies.

Gender

ALL

Eligibility 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