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

September 5, 2017 updated by: Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Antioxidant defence mechanisms include cellular and extracellular enzymes. Vitamin E is the main fat-soluble vitamin responsible for the protection of cell membranes against peroxidation, thus, it protects polyunsaturated fatty acids from peroxidation which is a step in the pathogenesis of ROP.

Previous research on the roles of vitamin E, in the prevention of BPD and ROP was halted because of complications involving sepsis and necrotising enterocolitis. These complications were caused by the compositions of vitamin E oral presentations, which contain polyethylene glycol, propylene glycol, ethanol and, polysorbate 80. These substances, which are used as excipients, may generate adverse effects in premature newborns. These preparations were not used in this project to avoid the development of necrotising enterocolitis, and because these formulations are not commercially available in Mexico.

The infants were randomly assigned to one of two groups using a computerized random number generator sequence; this process was handled by the hospital pharmacy staff. The treated group, received vitamin E 12.5 IU orally every 12 hours, from 72 h after birth until 28 days of age, the first blood sample collected from the newborns before the intervention was considered the baseline, and subsequent samples were obtained at 15 and 28 days of age.

Control group: received orally sterile water (placebo)

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment A
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
Placebo Comparator: Treatment B
Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of retinopathy of prematurity
Time Frame: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of bronchopulmonary dysplasia (BPD)
Time Frame: Incidence of BPD was measured in each participant at 28 days old.
BPD diagnosis was established according to the National Institute of Child Health and Human Development (NICHD) Workshop summary.
Incidence of BPD was measured in each participant at 28 days old.
Severity of bronchopulmonary dysplasia (BPD)
Time Frame: Severity of BPD was measured at corrected 36 weeks' gestational age.
Severity was classified into one of three stages: mild, when the patient did not required oxygen; moderate, when the patient required 30% oxygen; and severe when the patient required >30% oxygen, had nasal continuous positive airway pressure (CPAP), or mechanical ventilation.
Severity of BPD was measured at corrected 36 weeks' gestational age.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Investigators

  • Principal Investigator: Silvia Romero-Maldonado, M.Sc., Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 5, 2017

First Posted (Actual)

September 7, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2017

Last Update Submitted That Met QC Criteria

September 5, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 212250-10231

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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