Bronchopulmonary DysplasiaNCT01439295
Ascorbyl Peroxide Association With Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation. Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Bronchopulmonary Dysplasia
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2010to Nov 2015
- Phase
- Observational
- 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants less than 33 weeks of getation
Who may be able to join
- Preterm infants less than 33 weeks of gestation<
- Admission to CHU Sainte-JUstien neonatal intensive care unit
- Receiving Parenteral nutrition during the first week of life
- Parental consent
Who cannot join
- Major congenital anomalies
- Sever perinatal asphyxia
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Montreal, Sainte-Justine Hospital
Montreal, Quebec, H3T1C5
About this study
Official title: Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
Read the detailed description
This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia).
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Ascorbyl peroxide, Bronchopulmonary dysplasia, Redox status, Necrotising entercolitis, Retinopathy of prematurity, Patent ductus arteriosus, Intraventricular hemorrhage, Periventricular leucomalacia
- Medical subject headings
- Bronchopulmonary Dysplasia, Retinopathy of Prematurity, Ductus Arteriosus, Patent, Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Preterm less than 33 weeks | This cohort will be composed of premature infants born before 33 weeks of gestational age, admitted to the neonatal intensive care unit at Sainte-Justine hospital and receiving parenteral nutrition (PN) during their first week of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bronchopulmonary Dysplasia
To correlate the level of urinary Ascorbyl peroxide and BPD. Full diagnosis and classification (to mild, moderate or severe) is at 36 weeks of corrected age; so even for most premature infants (like 23 weeks of gestation) there will be a need for follow up for less than 4 month to have the final diagnosis at 36 weeks
Measured: 4 Months
Secondary outcomes (2)
The redox status (in blood)
Testing the correlation between the urinary level of ascorbyl peroxide and the redox status in the blood at 5 to 7 days of life. Measuring the Redox potential at 36 weeks corrected age to investigate long term effect of early oxidative stress.
Measured: First week of life (week 1) and 36 semaines CA
Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)
These outcomes are the major neonatal outcomes for preterm infants, we would test the correlation between ascorbyl peroxide (as marker of oxidative stress) and like Necrotising enterocolotis (NEC), Retinopathy of prematurity (ROP),patent ductus arteriosis(PDA), intraventricular hemorrhage (IVH) and periventricular leucomalacia (PVL).
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Ibrahim Mohamed, St. Justine's Hospital
- Investigators
- Ibrahim Mohamed, Mb CHB, Principal investigator, University of Montreal, Sainte Justine HospitalJean-claude Lavoie, PhD, Study director, University of Montreal, Sainte-Justine hospital research center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439295
- Sponsor's protocol ID
- University of Montreal
- Other IDs
- CIHR246505
- Status last verified
- Nov 2015
- First submitted
- 16 Sep 2011
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Ascorbyl Peroxide as an Early Biological Marker of Bronchopulmonary Dysplasia in Preterm Infants Less Than 33 Weeks of Gestation
- ClinicalTrials.gov ID
- NCT01439295
- Acronym / sponsor ID
- University of Montreal
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Ascorbyl peroxide, Bronchopulmonary dysplasia, Redox status, Necrotising entercolitis, Retinopathy of prematurity, Patent ductus arteriosus, Intraventricular hemorrhage, Periventricular leucomalacia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 23 Sep 2011 (estimated)
- 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.
Urinary ascorbyl peroxide level in the first week of life will be a good predictor of Bronchopulmonary dysplasia (BPD) in preterm infants less than 33 weeks of gestation.
Detailed description
This study uses ascorbyl peroxide as representative of oxidative stress in premature infants on parenteral nutrition and aims to test the correlation of this metabolite and the different major neonatal outcomes 'mainly bronchopulmonary dysplasia).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm less than 33 weeks | – | –This cohort will be composed of premature infants born before 33 weeks of gestational age, admitted to the neonatal intensive care unit at Sainte-Justine hospital and receiving parenteral nutrition (PN) during their first week of life. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants less than 33 weeks of getation
Key inclusion criteria (4 listed)
- Preterm infants less than 33 weeks of gestation<
- Admission to CHU Sainte-JUstien neonatal intensive care unit
- Receiving Parenteral nutrition during the first week of life
- Parental consent
Key exclusion criteria (2 listed)
- Major congenital anomalies
- Sever perinatal asphyxia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bronchopulmonary Dysplasia
Time frame: 4 Months
To correlate the level of urinary Ascorbyl peroxide and BPD. Full diagnosis and classification (to mild, moderate or severe) is at 36 weeks of corrected age; so even for most premature infants (like 23 weeks of gestation) there will be a need for follow up for less than 4 month to have the final diagnosis at 36 weeks
2 secondary outcomes
The redox status (in blood)
Time frame: First week of life (week 1) and 36 semaines CA
Major neonatal outcomes (NEC, ROP, PDA, IVH, PVL)
Time frame: 4 Months
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 18 Nov 2015.
- Admixture of a Multivitamin Preparation to Parenteral Nutrition: The Major Contributor to In Vitro Generation of PeroxidesLink provided by the sponsor.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Ibrahim Mohamed, Mb CHB principal investigator
University of Montreal, Sainte Justine Hospital
Jean-claude Lavoie, PhD study director
University of Montreal, Sainte-Justine hospital research center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by St. Justine's Hospital at 1 site in Canada.
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 4 inclusion and 2 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 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Bronchopulmonary Dysplasia (time frame: 4 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2015.