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Completed

NCT Number: NCT03274596

Effect of Vitamin E for Prevention of Retinopathy of Prematurity: 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.

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Key information

Conditions

Retinopathy of Prematurity Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Retinal Diseases

Age range

3 day–3 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E

Drug

Placebo

Drug

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Other Gov

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 7, 2017
Registry last updated
Sep 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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