None listed
Conditions
Brief summary
Vitamin A is required for the development and growth of lungs in premature babies who are born with low vitamin A body stores. Supplementing premature babies with additional doses of vitamin A by intramuscular injections decreases bronchopulmonary dysplasia (BPD - a chronic lung disease related to premature birth). As intramuscular injections are painful, the supplementation has not been widely practiced. Oral vitamin A, especially fat soluble form, is poorly absorbed by premature babies and therefore may be less effective. This study aims to investigate if supplementation of water soluble form, which is better absorbed, to extremely premature babies decreases risk of BPD. As a part of the study we are also looking at if we can use saliva to assess vitamin A status instead of blood in the babies. .
Interventions
Enteral water-miscible vitamin A 5000 IU (0.5 mL) once daily started within 24 hours of the introduction of oral feeds and continued until 34 week post-menstrual age. The trial medication will be prescribed on the routinely used medication charts in the neonatal nursery and the medication will be administered by a nurse caring for the baby. The nurse will document the administration of the medication in the medication chart. The charts will be reviewed every week to ensure compliance.
Sponsors
Abhijeet Rakshasbhuvankar
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 72 Hours
Healthy volunteers
No
Inclusion criteria
Gestational age at birth less than 28 weeks and postnatal age less than 72 hours and Informed parental consent
Exclusion criteria
Congenital gastrointestinal and respiratory tracts abnormalities
Outcome results
None listed