NCT03876704

Effects of Fat-soluble Vitamins Supplementation on Common Complications and Neural Development in Very Low Birth Weight Infants

Effects of Fat-soluble Vitamins Supplementation in Early Life on Common Complications and Neural Development in Very Low Birth Weight Infants

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 24 Hours
• Healthy volunteers: Not accepted

Summary

Vitamins A, D, and E play important roles in humans, such as vision function, immune function, bone metabolism, cell growth and differentiation and oxidation resistance. Deficiencies in these vitamins will result in a high prevalence of cardiovascular disease, infection, bone diseases, etc. Preterm infants, especially very low birth weight infants, are at risk of vitamin deficiency. Intravenous perfusion is the most common and widely used method to supply vitamins for the specific population in early life. However, the current dose of vitamin supplied by intravenous perfusion whether can meet the need of growth and development is not sure and the appropriate dose for preterm infants is still uncertain. The purpose of this study is to investigate whether current dose of fat-soluble vitamin supplementation is enough for very low birth weight infants, the safety of high dose of fat-soluble vitamin supplementation, and compare the differences of prevalence of common complications, such as bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, and neural development between these two groups.

Conditions

• Vitamin A Deficiency
• Vitamin D Deficiency
• Vitamin E Deficiency
• Very Low Birth Weight Infants
• Bronchopulmonary Dysplasia
• Anemia
• Sepsis

Interventions

Type	Name	Description
DRUG	High dose of fat-Soluble Vitamin	Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
DRUG	Conventional dose of fat-Soluble Vitamin	Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Timeline

• Start date: 2019-01-29
• Primary completion: 2019-09-30
• Completion: 2020-12-31
• First posted: 2019-03-15
• Last updated: 2019-03-15

Locations

1 site across 1 country: China