Retinopathy of PrematurityNCT03274596
Effect of Vitamin E for Prevention of Retinopathy of Prematurity: A Randomized Clinical Trial.
A study testing Vitamin E in people with Retinopathy of Prematurity, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 3 days
- Conditions the study is for
- Retinopathy of Prematurity
- What is being tested?
- Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn weight < 1500 g
- Diagnosed respiratory distress syndrome (RDS)
- Patients who required mechanical ventilation or CPAP
Who cannot join
- Congenital malformations
- Rh incompatibility
- Non-immune or immune hydrops fetalis
- Intraventricular haemorrhage III/IV grade
About this study
Official title: Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.
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.
Read the 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)
- Conditions
- Retinopathy of Prematurity
- Being tested
- Vitamin E, Placebo
- Keywords
- Oxidative Damage, Vitamin E, Total Antioxidant Capacity, Retinopathy of Prematurity
- Medical subject headings
- Retinopathy of Prematurity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin EDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | Group A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old. Receives: Drug: Vitamin E |
| Treatment B | Placebo comparator | Group B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of retinopathy of prematurity
Retinopathy of prematurity was classified according to the International Classification of Retinopathy of Prematurity revisited 2005.
Measured: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.
Secondary outcomes (2)
Incidence of bronchopulmonary dysplasia (BPD)
BPD diagnosis was established according to the National Institute of Child Health and Human Development (NICHD) Workshop summary.
Measured: 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.
Measured: Severity of BPD was measured at corrected 36 weeks' gestational age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Mar 2013
- Primary completion1 Oct 2015
- Study completion1 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinopathy of PrematurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Silvia Romero-Maldonado, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Investigators
- Silvia Romero-Maldonado, M.Sc., Principal investigator, Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274596
- Sponsor's protocol ID
- 212250-10231
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34397821
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin E Supplementation on Oxidative Stress and Retinopathy of Prematurity in Preterm Infants <1500 g: A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03274596
- Acronym / sponsor ID
- 212250-10231
- Conditions
- Retinopathy of Prematurity
- Keywords
- Oxidative Damage, Vitamin E, Total Antioxidant Capacity, Retinopathy of Prematurity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Oct 2015 (actual)
- Study completion
- 1 Dec 2015 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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,
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: Vitamin EGroup A: received 12.5 IU of vitamin E orally every 12 hours, from 72 h of birth to 28 days old. |
| Treatment B | Placebo comparator | Drug: PlaceboGroup B: received 12.5 IU of placebo orally every 12 hours, from 72 hours of birth to 28 days old. |
Who may qualify
- Ages
- 3 to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborn weight < 1500 g
- Diagnosed respiratory distress syndrome (RDS)
- Patients who required mechanical ventilation or CPAP
Key exclusion criteria (4 listed)
- Congenital malformations
- Rh incompatibility
- Non-immune or immune hydrops fetalis
- Intraventricular haemorrhage III/IV grade
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin E | Drug | Treatment A |
| Placebo | Drug | Treatment B |
Primary outcome
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.
2 secondary outcomes
Incidence of bronchopulmonary dysplasia (BPD)
Time frame: Incidence of BPD was measured in each participant at 28 days old.
Severity of bronchopulmonary dysplasia (BPD)
Time frame: Severity of BPD was measured at corrected 36 weeks' gestational age.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
- Derived from this study: PubMed 34397821Romero-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Romero-Maldonado, M.Sc. principal investigator
Instituto Nacional de Perinatología Isidro Espinosa de los Reyes
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin E in people with Retinopathy of Prematurity, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of retinopathy of prematurity (time frame: For the first retinopathy diagnosis, ophthalmological evaluation was performed at 28 days of birth.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2017.