Retinopathy of Prematurity
Conditions
Keywords
Oxidative Damage, Vitamin E, Total Antioxidant Capacity, Retinopathy of Prematurity
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)
Interventions
DRUGVitamin E
DRUGPlacebo
Sponsors
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, 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.
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,
Eligibility
Sex/Gender
ALL
Age
3 Days to 3 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of retinopathy of prematurity | 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence of bronchopulmonary dysplasia (BPD) | 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) | 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. |
Outcome results
None listed