Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.

NCT03274596 | Completed DMC

• 1 other identifier: 212250-10231
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The retinopathy of prematurity (ROP) is a public health problem, the main causes of ROP are prematurity, use of oxygen, malnutrition and oxidative stress. Vitamin E was used beforehand however its use was stopped because of its association with sepsis and enterocolitis caused by the excipient of vitamin E. The purpose of this study is to use vitamin E to prevent ROP, without the previously used excipients.

Conditions

Retinopathy of Prematurity

Keywords

Oxidative Damage; Vitamin E; Total Antioxidant Capacity; Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (1)

• Incidence of retinopathy of prematurity

  Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.

  For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.

Secondary Outcomes (2)

• Incidence of bronchopulmonary dysplasia (BPD)

  Incidence of BPD was measured in each participant at 28 days old.

• Severity of bronchopulmonary dysplasia (BPD)

  Severity of BPD was measured at corrected 36 weeks' gestational age.

Study Arms (2)

Treatment A

ACTIVE COMPARATOR

Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old.

Drug: Vitamin E

Treatment B

PLACEBO COMPARATOR

Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.

Drug: Placebo

Interventions

Vitamin E DRUG

Treatment A

Placebo DRUG

Treatment B

Eligibility Criteria

• Age: 3 Days - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn weight \< 1500 g
• Diagnosed respiratory distress syndrome (RDS)
• Patients who required mechanical ventilation or CPAP

You may not qualify if:

• Congenital malformations
• Rh incompatibility
• Non-immune or immune hydrops fetalis
• Intraventricular haemorrhage III/IV grade

Sponsors & Collaborators

• Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes: lead

Related Publications (1)

• Romero-Maldonado S, Montoya-Estrada A, Reyes-Munoz E, Guzman-Grenfell AM, Torres-Ramos YD, Sanchez-Mendez MD, Tolentino-Dolores M, Salgado-Valladares MB, Belmont-Gomez A, Najera N, Ceballos G, Cardona-Perez JA, Hicks JJ, Mancilla-Ramirez J. Efficacy of water-based vitamin E solution versus placebo in the prevention of retinopathy of prematurity in very low birth weight infants: A randomized clinical trial. Medicine (Baltimore). 2021 Aug 6;100(31):e26765. doi: 10.1097/MD.0000000000026765.

  PMID: 34397821 DERIVED

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Silvia Romero-Maldonado, M.Sc.

  Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The placebo was made by a pharmacologist and was the only person who knows the treatment of A and B. The placebo was administered by nursing staff and had the same appearance and amount as vitamin E. Neither the parents of the participants nor the researchers involved in the care or analysis of the data knew the content of the treatment and B until the end of the study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: participants were randomly assigned to one of two treatmenst (A and B) using a computarized random number generator sequence; this process was handled by the hospital pharmacy staff. Group A: received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, Group B: received orally sterile water (placebo) orally every 12 hours, from 72 h after birth until 28 days of age,

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 7, 2017
• Study Start: March 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 7, 2017

Record last verified: 2017-09