NCT05311540

Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 195 (actual)
• Sponsor: Zekai Tahir Burak Women's Health Research and Education Hospital · Academic / Other
• Sex: All
• Age: 7 Days – 9 Days
• Healthy volunteers: Not accepted

Summary

* Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems. * Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life. * Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status. * There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants. * Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Detailed description

Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS). Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of \<32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.

Conditions

• Preterm Infant
• Effect of Drugs
• Zinc Deficiency Disease

Interventions

Type	Name	Description
DRUG	Zinc Sulfate

Timeline

• Start date: 2014-03-14
• Primary completion: 2015-03-02
• Completion: 2015-04-20
• First posted: 2022-04-05
• Last updated: 2023-02-08

Locations

1 site across 1 country: Turkey (Türkiye)