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

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ClinicalTrials.gov Identifier: NCT02102711
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : March 22, 2019
Sponsor:
Collaborator:
IRCCS Policlinico S. Matteo
Information provided by (Responsible Party):
Lidia Decembrino, IRCCS Policlinico S. Matteo

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.


Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Retinopathy of Prematurity Dietary Supplement: Vitamin A oral drops Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2016


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 Name: VISPO, BIOTRADING Pharma

No Intervention: control
Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)



Primary Outcome Measures :
  1. Vitamin A blood concentration (µM/L) [ Time Frame: participants will be followed for the duration of Vitamin A oral administration, an expected average of 4 weeks ]
    Vitamin A functional concentration


Secondary Outcome Measures :
  1. number of bronchopulmonary dysplasia and of retinopathy of prematurity [ Time Frame: 1 year ]
    number of events



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102711


Locations
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Italy
IRCCS Policlinico S. Matteo
Pavia, PV, Italy, 27100
IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit
Pavia, Italy, 27100
Sponsors and Collaborators
Lidia Decembrino
IRCCS Policlinico S. Matteo
Investigators
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Study Director: Mauro Stronati, MD IRCCS Policlinico S. Matteo, Pavia, Italy

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Responsible Party: Lidia Decembrino, doctor, IRCCS Policlinico S. Matteo
ClinicalTrials.gov Identifier: NCT02102711     History of Changes
Other Study ID Numbers: VITA-1-OS
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lidia Decembrino, IRCCS Policlinico S. Matteo:
VITAMIN A
BLOOD CONCENTRATION
retinopathy of prematurity

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Birth Weight
Bronchopulmonary Dysplasia
Eye Diseases
Body Weight
Signs and Symptoms
Obstetric Labor Complications
Pregnancy Complications
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Newborn, Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents