An interventional study of Vitamin A oral drops in Bronchopulmonary Dysplasia and Retinopathy of Prematurity, sponsored by Francesca Garofoli. Completed at 2 sites in Italy. Open to participants aged 1 Day to 7 Days. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Francesca Garofoli · Not applicable, Interventional, and Treatment
Vitamin A is essential for optimal growth, and development. In the newborn, especially if preterm, it is necessary for the cellular differentiation, for the health of the anterior eye, it is a constituent of visual pigment, and it is essential for surfactant synthesis. Immune response Vitamin A supplementation demonstrated to reduces infancy mortality, but very low (\<1500g birth weight) and extremely low (\<1000g birth weight) preterm infants are born with low body stores of vitamin A and are at high risk of vitamin A deficiency. Nevertheless, optimal vitamin A supplementation for these infants is not clearly defined, despite evidence of benefit of an early supplementation.
Prematurity is associate to the risk for bronchopulmonary dysplasia (BPD) which is a disease marked by respiratory compromise associated with high mortality and severe long-term morbidity, as well as prematurity is associate to the risk for retinopathy, a pathology that may be related to less rhodopsin quantity which seem dependent on vitamin A concentration. Vitamin A can be given enterally, intramuscularly, or intravenously. Recently an oral administration as drops is available resulting particularly convenient avoiding the pain associated with repetitive intramuscular injections, or the discomfort of parenteral administration. Studies of vitamin A in the infant population suggest that plasma retinol concentrations >0.7 µM/L indicate vitamin A sufficiency, nevertheless preterm infants have lower concentration and concentration \< 0.35 µM/L are very dangerous. Vitamin A deficiency at this level may constitute a problem for preterm newborn, resulting for example, in histological alterations in the respiratory epithelium leading to chronic lung disease, retinopathy of prematurity, patency of the ductus arteriosis, and immune competence deficiency.
The aim of the present study is to verify efficacy and tolerability of a new oral administration of vitamin A as drops, 3000 IU/kg/die for 4 weeks, in infants \< 1500g weight at birth, verifying the competence of the supplementation reaching ideal blood concentration (≥0.7 µM/L) and relating the blood achieved concentrations of vitamin A to the outcome in typical pathologies, as BPD and ROP. Not treated group of matched newborn infants is the controlarm.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 62 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Francesca Garofoli is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.
Dietary Supplement: Vitamin A oral drops
Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)
Also known as: VISPO, BIOTRADING Pharma
Vitamin A blood concentration (µM/L)
Vitamin A functional concentration
Time frame: participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks
number of bronchopulmonary dysplasia and of retinopathy of prematurity
number of events
Time frame: 1 year
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Francesca Garofoli