Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
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|ClinicalTrials.gov Identifier: NCT03274596|
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Retinopathy of Prematurity||Drug: Vitamin E Drug: Placebo||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|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,|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||The placebo was made by a pharmacologist and was the only person who knows the treatment of A and B. The placebo was administered by nursing staff and had the same appearance and amount as vitamin E. Neither the parents of the participants nor the researchers involved in the care or analysis of the data knew the content of the treatment and B until the end of the study.|
|Official Title:||Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.|
|Actual Study Start Date :||March 1, 2013|
|Actual Primary Completion Date :||October 1, 2015|
|Actual Study Completion Date :||December 1, 2015|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03274596
|Principal Investigator:||Silvia Romero-Maldonado, M.Sc.||Instituto Nacional de Perinatología Isidro Espinosa de los Reyes|