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

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)

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.

Study Overview

• Status: Completed
• Conditions: Retinopathy of Prematurity; Bronchopulmonary Dysplasia
• Intervention / Treatment: Dietary supplement: Vitamin A oral drops

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Pavia, Italy, 27100
    • IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
  • PV
    • Pavia, PV, Italy, 27100
      • IRCCS Policlinico S. Matteo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 week (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: vitaminA drops; 3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.	Dietary supplement: Vitamin A oral drops; Other Names: VISPO, BIOTRADING Pharma
No Intervention: control; Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitamin A blood concentration (µM/L)	Vitamin A functional concentration	participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of bronchopulmonary dysplasia and of retinopathy of prematurity	number of events	1 year

Collaborators and Investigators

• Sponsor: Francesca Garofoli
• Collaborators: Fondazione IRCCS Policlinico San Matteo di Pavia
• Investigators: Study Director: Mauro Stronati, MD, IRCCS Policlinico S. Matteo, Pavia, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 6, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimated): April 3, 2014

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: retinopathy of prematurity; VITAMIN A; BLOOD CONCENTRATION
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Eye Diseases; Infant, Newborn, Diseases; Body Weight; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Retinal Diseases; Premature Birth; Birth Weight; Retinopathy of Prematurity; Bronchopulmonary Dysplasia; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin A
• Other Study ID Numbers: VITA-1-OS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO