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

NCT ID: NCT03274596

Last Updated: 2017-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2015-12-01

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)

Conditions

Retinopathy of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment A

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

Group Type: ACTIVE_COMPARATOR

Vitamin E

Intervention Type: DRUG

Treatment B

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

Vitamin E

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

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

• Minimum Eligible Age: 3 Days
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

OTHER_GOV

Sponsor Role: lead

Responsible Party

Silvia Romero-Maldonado

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvia Romero-Maldonado, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

References

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.

Reference Type: DERIVED

PMID: 34397821 (View on PubMed)

Other Identifiers

212250-10231

Identifier Type: -

Identifier Source: org_study_id