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

Xi'an Jiaotong University

Status and phase: Unknown; Phase 3

Conditions: Anemia; Very Low Birth Weight Infants; Vitamin A Deficiency; Vitamin D Deficiency; Vitamin E Deficiency; Bronchopulmonary Dysplasia; Sepsis

Treatments: Drug: High dose of fat-Soluble Vitamin; Drug: Conventional dose of fat-Soluble Vitamin

Study type: Interventional

Funder types: Other

Identifiers

NCT03876704

2018MSZC-04

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 24 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

High dose of fat-soluble vitamins

Experimental group

Description:

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.

Treatment:

Drug: High dose of fat-Soluble Vitamin

Conventional dose of fat-soluble vitamins

Active Comparator group

Description:

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.

Treatment:

Drug: Conventional dose of fat-Soluble Vitamin