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Trial record 2 of 293 for:    retinopathy of prematurity

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
Sponsor:
Information provided by (Responsible Party):
Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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.

Condition or disease Intervention/treatment Phase
Retinopathy of Prematurity Drug: Vitamin E Drug: Placebo Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
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.
Primary Purpose: Prevention
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


Arm Intervention/treatment
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.
Drug: Placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
Investigators
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Principal Investigator: Silvia Romero-Maldonado, M.Sc. Instituto Nacional de Perinatología Isidro Espinosa de los Reyes

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Responsible Party: Silvia Romero-Maldonado, Principal Investigator, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT03274596     History of Changes
Other Study ID Numbers: 212250-10231
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes:
Oxidative Damage
Vitamin E
Total Antioxidant Capacity
Retinopathy of Prematurity

Additional relevant MeSH terms:
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Retinal Diseases
Premature Birth
Retinopathy of Prematurity
Obstetric Labor, Premature
Infant, Premature, Diseases
Eye Diseases
Obstetric Labor Complications
Pregnancy Complications
Infant, Newborn, Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents