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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-29

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin A Supplementation in Preterm Infants

NCT00063596

Infant, Premature

UNKNOWN NA

Vitamin A and Very Low Birthweight Babies (VitAL)

NCT00417404

Preterm Birth Retinopathy of Prematurity

COMPLETED PHASE4

Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g

NCT02102711

Bronchopulmonary Dysplasia Retinopathy of Prematurity

COMPLETED NA

Vitamin A for BPD Prevention

NCT04563429

The Relationship Between Oral Vitamin A Administration and the Incidence of BPD in Preterm Infants Born Before Week 29 of Pregnancy

UNKNOWN NA

B Vitamin Status in Premature and Small for Gestational Age(SGA) Infants

NCT01201005

Biochemical Cobalamin Status Motor Neurodevelopment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High dose of fat-soluble vitamins

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.

Group Type EXPERIMENTAL

High dose of fat-Soluble Vitamin

Intervention Type DRUG

Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion

Conventional dose of fat-soluble vitamins

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.

Group Type ACTIVE_COMPARATOR

Conventional dose of fat-Soluble Vitamin

Intervention Type DRUG

Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High dose of fat-Soluble Vitamin

Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion

Intervention Type DRUG

Conventional dose of fat-Soluble Vitamin

Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No