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

NCT ID: NCT02102711

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Bronchopulmonary Dysplasia; Retinopathy of Prematurity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

vitaminA drops

3000 IU/kg/die of Vitamin A oral drops, for 4 weeks.

Group Type: EXPERIMENTAL

Vitamin A oral drops

Intervention Type: DIETARY_SUPPLEMENT

control

Control of matched infants not supplemented with vitamin A ( beyond standard/routine needed)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Vitamin A oral drops

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

VISPO, BIOTRADING Pharma

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Francesca Garofoli

OTHER

Sponsor Role: lead

Responsible Party

Francesca Garofoli

doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mauro Stronati, MD

Role: STUDY_DIRECTOR

IRCCS Policlinico S. Matteo, Pavia, Italy

Locations

IRCCS Policlinico S. Matteo

Pavia, PV, Italy

IRCCS Policlinico S.Matteo; Neonatal Intensive Care Unit

Pavia, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32493448 (View on PubMed)

Other Identifiers

VITA-1-OS

Identifier Type: -

Identifier Source: org_study_id