Clinical trial NCT03274596: Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
Official title: Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Keywords: Oxidative Damage
Vitamin E
Total Antioxidant Capacity
Retinopathy of Prematurity
Lead sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Sponsor class: OTHER_GOV
First posted: 2017-09-07
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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,
Primary purpose: PREVENTION

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of retinopathy of prematurity
timeFrame: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.
Secondary outcomes:
measure: Incidence of bronchopulmonary dysplasia (BPD)
timeFrame: Incidence of BPD was measured in each participant at 28 days old.
measure: Severity of bronchopulmonary dysplasia (BPD)
timeFrame: Severity of BPD was measured at corrected 36 weeks' gestational age.
Other outcomes:
Locations:
Study officials:
affiliation: Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
name: Silvia Romero-Maldonado, M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.