Development of Control of BreathingPhase 2/3NCT00573053
Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
A Phase 2/3 study testing Oxygen saturation range in people with Development of Control of Breathing, run by University of Manitoba at 2 sites in Canada.
Trial summary
To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants. Read more about this study
- Who is it for?
- Ages 21 to 70 days
- Conditions the study is for
- Development of Control of Breathing
- What is being tested?
- Oxygen saturation range
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2007to Jan 2011
- Phase
- Phase 2/3
- 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 21 to 70 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age 23 0/7 - 27 6/7 weeks
- Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
- Postnatal age between 21 days and 70 days
- Informed written consent obtained from at least one of the parents.
Who cannot join
- Need for mechanical ventilation, NCPAP or O2
- Sepsis or other known causes of apnea.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
Health Science Centre
Winnipeg, Manitoba, R3E 0L8
About this study
To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.
Read the detailed description
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:
- The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs
- Conditions
- Development of Control of Breathing
- Being tested
- Oxygen saturation range
- Keywords
- hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen saturation rangeOther
Maintain functional oxygen saturation range between 91 and 95%
Oxygen saturation rangeOther
Maintain functional arterial oxygen saturations in the range of 85- 89%
| Study group | Role | What they receive |
|---|---|---|
| High | Active comparator | Arterial oxygen saturations in the range of 91-95% Receives: Other: Oxygen saturation range |
| Low | Experimental | Arterial oxygen saturations in the range of 85-89% Receives: Other: Oxygen saturation range |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
Measured: 3 months
Secondary outcomes (1)
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2007 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of Control of BreathingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Ruben E Alvaro, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00573053
- Sponsor's protocol ID
- B2007:157
- Status last verified
- Jan 2011
- First submitted
- 11 Dec 2007
- Last updated
- 19 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Targeting Lower Arterial Oxygen Saturations on the Development of Control of Breathing in Very Preterm Infants
- ClinicalTrials.gov ID
- NCT00573053
- Acronym / sponsor ID
- B2007:157
- Conditions
- Development of Control of Breathing
- Keywords
- hypercapneic response, hyperoxic response, breathing pattern, periodic breathing, sighs
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 13 Dec 2007 (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.
To determine whether targeting lower arterial oxygen saturations from the day of birth alters the early (first 3 months) postnatal development of the control of ventilation and the hypercapnic and hyperoxic responses in very preterm infants.
Detailed description
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on:
- The early (first 5 breaths) and late or steady state (3-5 minutes) ventilatory response to CO2 ii) The immediate (< 1 minute) ventilatory response to hyperoxia iii) The PCO2 apneic threshold iv) The breathing pattern during quiet and REM sleep v) The morphology of periodic breathing cycles vi) The incidence and morphology of sighs
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High | Active comparator | Other: Oxygen saturation rangeArterial oxygen saturations in the range of 91-95% |
| Low | Experimental | Other: Oxygen saturation rangeArterial oxygen saturations in the range of 85-89% |
Who may qualify
- Ages
- 21 to 70 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age 23 0/7 - 27 6/7 weeks
- Enrolled in the COT trial at the Health Sciences Centre and the St. Boniface General Hospital in Winnipeg
- Postnatal age between 21 days and 70 days
- Informed written consent obtained from at least one of the parents.
Key exclusion criteria (2 listed)
- Need for mechanical ventilation, NCPAP or O2
- Sepsis or other known causes of apnea.
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 |
|---|---|---|
| Oxygen saturation rangeMaintain functional oxygen saturation range between 91 and 95% | Other | High |
| Oxygen saturation rangeMaintain functional arterial oxygen saturations in the range of 85- 89% | Other | Low |
Primary outcome
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants
Time frame: 3 months
1 secondary outcome
To measure the effects of baseline oxygenation in extremely low birth weight preterm infants on the ventilatory response to CO2 and O2, the PCO2 apneic threshold, and the baseline breathing pattern
Time frame: 3 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 19 Apr 2011.
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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.
Ruben E Alvaro, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Oxygen saturation range in people with Development of Control of Breathing, run by University of Manitoba at 2 sites 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effects of targeting lower arterial oxygen saturations on the development of control of breathing in very preterm infants (time frame: 3 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 19 Apr 2011.