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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2015

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)

Interventions

  • Drug: Vitamin E
  • Drug: Placebo

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 3 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Provider of Information About this Clinical Study
    • Principal Investigator: Silvia Romero-Maldonado, Principal Investigator – Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
  • Overall Official(s)
    • Silvia Romero-Maldonado, M.Sc., Principal Investigator, Instituto Nacional de Perinatolog√≠a Isidro Espinosa de los Reyes

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