Anemia, Bronchopulmonary Dysplasia, Sepsis, Very Low Birth Weight Infants, Vitamin A Deficiency, Vitamin D Deficiency, Vitamin E Deficiency
Conditions
Brief 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.
Interventions
DRUGHigh dose of fat-Soluble Vitamin
Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
DRUGConventional dose of fat-Soluble Vitamin
Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
Sponsors
Xi'an Gaoxin Hospital
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitamin levels | within 72 hours after birth, 4~6 weeks old | Change from baseline level of vitamin A, vitamin D, and vitamin E at 4\ 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | corrected age of 36 weeks | The prevalence of bronchopulmonary dysplasia, patent ductus arteriosus, sepsis, anemia, intracranial hemorrhage, extrauterine growth retardation, etc. |
| Neural development | corrected age of 40 weeks | White matter disease of the preterm infant, was semiquantitatively assessed from MRI at term-equivalent age based on an established scoring method. |
| Gene polymorphism in vitamin deficiency preterm infants | within 72 hours after birth, 4~6 weeks old | Association of rs4588 polymorphism in vitamin D receptor gene and rs10766197 polymorphism in the cytochrome P450 family 2 subfamily R member 1 gene with baseline level of vitamin D and change in vitamin D level after 4\ 6 weeks' supplementation |
Countries
China
Contacts
Primary ContactShuang Liu
Outcome results
None listed