Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
Primary Purpose
Retinopathy of Prematurity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Vitamin E
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Retinopathy of Prematurity focused on measuring Oxidative Damage, Vitamin E, Total Antioxidant Capacity, Retinopathy of Prematurity
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment A
Treatment B
Arm Description
Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old.
Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.
Outcomes
Primary Outcome Measures
Incidence of retinopathy of prematurity
Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.
Secondary Outcome Measures
Incidence of bronchopulmonary dysplasia (BPD)
BPD diagnosis was established according to the National Institute of Child Health and Human Development (NICHD) Workshop summary.
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.
Full Information
NCT ID
NCT03274596
First Posted
September 4, 2017
Last Updated
September 5, 2017
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
1. Study Identification
Unique Protocol Identification Number
NCT03274596
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
October 1, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinopathy of Prematurity
Keywords
Oxidative Damage, Vitamin E, Total Antioxidant Capacity, Retinopathy of Prematurity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment A
Arm Type
Active Comparator
Arm Description
Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old.
Arm Title
Treatment B
Arm Type
Placebo Comparator
Arm Description
Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old.
Intervention Type
Drug
Intervention Name(s)
Vitamin E
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence of retinopathy of prematurity
Description
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.
Secondary Outcome Measure Information:
Title
Incidence of bronchopulmonary dysplasia (BPD)
Description
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.
Title
Severity of bronchopulmonary dysplasia (BPD)
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Romero-Maldonado, M.Sc.
Organizational Affiliation
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34397821
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.
Results Reference
derived
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Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
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