Trial | NCT03876704  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    120
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.
Study Started
Jan 29
2019
Primary Completion
Sep 30
2019
Anticipated
Study Completion
Dec 31
2020
Anticipated
Last Update
Mar 15
2019

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

High dose of fat-soluble vitamins Experimental

Fat-soluble vitamins is administered 0.5 piece/kg (equals to 1150 U/kg vitamin A，200 U/kg vitamin D, 3.2 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.

Conventional dose of fat-soluble vitamins Active Comparator

Fat-soluble vitamins is administered 0.1 piece/kg (equals to 230 U/kg vitamin A，40 U/kg vitamin D, 0.64 U/kg vitamin E) intravenously every day until the baby achieve full enteral feeding (120 ml/kg), starting with the first dose within 24 hours after birth.

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
No Results Posted