An interventional study of Vitamin E and Placebo in Retinopathy of Prematurity, sponsored by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes. Completed. Open to participants aged 3 Days to 3 Days. Per ClinicalTrials.gov, last updated 2017-09-07.
Sponsored by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes · Not applicable, Interventional, and Prevention
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.
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)
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's enrollment of 90 is close to the median of 82 across 102 interventional studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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
Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.
Drug: Placebo
Incidence of retinopathy of prematurity
Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.
Time frame: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.
Incidence of bronchopulmonary dysplasia (BPD)
BPD diagnosis was established according to the National Institute of Child Health and Human Development (NICHD) Workshop summary.
Time frame: Incidence of BPD was measured in each participant at 28 days old.
Severity of bronchopulmonary dysplasia (BPD)
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.
Time frame: Severity of BPD was measured at corrected 36 weeks' gestational age.
No study locations are listed for this record.
Ran from Mar 2013 to primary completion in Oct 2015, 31 months.
Of 28 non-industry interventional studies with no phase under Retinopathy of Prematurity, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's 31 months is above that.
Counting every sponsor, half of 30 studies reached it within 14 months; a quarter within 11 and three quarters within 31.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vitamin E
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes