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

Bronchopulmonary Dysplasia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102711
• Other study ID #: VITA-1-OS
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: March 2019
• Source: IRCCS Policlinico S. Matteo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Bronchopulmonary Dysplasia
• Premature Birth
• Retinal Diseases
• Retinopathy of Prematurity

Intervention

Dietary Supplement:
• Vitamin A oral drops

Locations

Country	Name	City	State
Italy	IRCCS Policlinico S. Matteo	Pavia	PV
Italy	IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Lidia Decembrino	IRCCS Policlinico S. Matteo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of bronchopulmonary dysplasia and of retinopathy of prematurity	number of events	1 year