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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Collaborators: Xi'an Gaoxin Hospital; Xi’an Gaoxin Hospital
• Treatments: Vitamins

Criteria

Inclusion Criteria:

• admitted to the neonatal intensive care unit (NICU) within 24 hours after birth

• gestational age younger than 34 weeks

• birth weight less than 1500 gram

• informed consent was obtained from the infants' parents or guardians

Exclusion Criteria:

• congenital malformation

• chromosomal disease, genetic metabolic diseases

• the infants or his/mother has abnormal thyroid function or parathyroid gland function

• neonatal necrotizing enterocolitis, diarrhea

• intracranial hemorrhage of 3 degrees or above

• pulmonary hemorrhage

• liver enzymes elevated by more than 2 times, cholestasis

• death or discharge against medical advice

• refuse to take part in the study