Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g
Primary Purpose
Bronchopulmonary Dysplasia, Retinopathy of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Vitamin A oral drops
Sponsored by
About this trial
This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring VITAMIN A, BLOOD CONCENTRATION, retinopathy of prematurity
Eligibility Criteria
Inclusion Criteria:
- parents signed informed consent
- very low birth weight infants undergoing ventilation for at least 24 hours
- Infants able to receive adequate breast or formula milk
Exclusion Criteria:
- parents denied informed consent
- congenital malformations
- infants not able to receive breast or formula milk
Sites / Locations
- IRCCS Policlinico S. Matteo
- IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
vitaminA drops
control
Arm Description
3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.
Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)
Outcomes
Primary Outcome Measures
Vitamin A blood concentration (µM/L)
Vitamin A functional concentration
Secondary Outcome Measures
number of bronchopulmonary dysplasia and of retinopathy of prematurity
number of events
Full Information
NCT ID
NCT02102711
First Posted
March 6, 2014
Last Updated
March 19, 2020
Sponsor
Lidia Decembrino
Collaborators
IRCCS Policlinico S. Matteo
1. Study Identification
Unique Protocol Identification Number
NCT02102711
Brief Title
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g
Official Title
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g Efficacy and Tolerability in the Prevention of Bronchopulmonary Dysplasia (BDP) and Retinopathy of the Prematurity (ROP)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lidia Decembrino
Collaborators
IRCCS Policlinico S. Matteo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Retinopathy of Prematurity
Keywords
VITAMIN A, BLOOD CONCENTRATION, retinopathy of prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vitaminA drops
Arm Type
Experimental
Arm Description
3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.
Arm Title
control
Arm Type
No Intervention
Arm Description
Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin A oral drops
Other Intervention Name(s)
VISPO, BIOTRADING Pharma
Primary Outcome Measure Information:
Title
Vitamin A blood concentration (µM/L)
Description
Vitamin A functional concentration
Time Frame
participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks
Secondary Outcome Measure Information:
Title
number of bronchopulmonary dysplasia and of retinopathy of prematurity
Description
number of events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
7 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
parents signed informed consent
very low birth weight infants undergoing ventilation for at least 24 hours
Infants able to receive adequate breast or formula milk
Exclusion Criteria:
parents denied informed consent
congenital malformations
infants not able to receive breast or formula milk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Stronati, MD
Organizational Affiliation
IRCCS Policlinico S. Matteo, Pavia, Italy
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Policlinico S. Matteo
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
City
Pavia
ZIP/Postal Code
27100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32493448
Citation
Garofoli F, Barilla D, Angelini M, Mazzucchelli I, De Silvestri A, Guagliano R, Decembrino L, Tzialla C. Oral vitamin A supplementation for ROP prevention in VLBW preterm infants. Ital J Pediatr. 2020 Jun 3;46(1):77. doi: 10.1186/s13052-020-00837-0.
Results Reference
derived
Learn more about this trial
Oral Vitamin A Supplementation in Neonates With Birth Weight < 1500 g
We'll reach out to this number within 24 hrs