Neonatal Respiratory FailurePhase 3BIPAPNCT01318824
A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
A Phase 3 study testing Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Bi-Level Positive Airway Pressure (BIPAP) in people with Neonatal Respiratory Failure, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Neonatal Respiratory Failure
- What is being tested?
- Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Bi-Level Positive Airway Pressure (BIPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Feb 2013
- Phase
- Phase 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn infants with birth weight > 500 gm.
- Gestational age > 24 completed weeks.
- Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
Who cannot join
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
- Infants who are > 28 days old and continue to require mechanical ventilation with an endotracheal tube
Trial locations and contacts
1 site in 1 country.
China1 site
Deaprtment of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
About this study
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.
Read the detailed description
Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.
- Conditions
- Neonatal Respiratory Failure
- Being tested
- Nasal Intermittent Positive Pressure Ventilation (NIPPV), Bi-Level Positive Airway Pressure (BIPAP)
- Keywords
- Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Intermittent Positive Pressure Ventilation (NIPPV)Procedure or surgery
Also called Nasal Intermittent Positive Pressure Ventilation
The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
Bi-Level Positive Airway Pressure (BIPAP)Procedure or surgery
Also called Bi-Level Positive Airway Pressure
BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
| Study group | Role | What they receive |
|---|---|---|
| I=NIPPV | Placebo comparator | This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment. Receives: Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV) |
| II=BiPAP | Experimental | This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment Receives: Procedure: Bi-Level Positive Airway Pressure (BIPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Measured: At 7 days, 28 days and at 36 weeks postmenstraul age
Secondary outcomes (1)
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
get the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
Measured: At 7 days, 28 days and at 36 weeks postmenstraul age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory FailureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Yuan Shi, MD, Study director, Department of Pediatrics, Daping Hospital, Third Military Medical UniversityShifang Tang, Principal investigator, Department of Pediatrics, Daping Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01318824
- Sponsor's protocol ID
- 2011002
- Acronym
- BIPAP
- Status last verified
- Jan 2011
- First submitted
- 23 Feb 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Bi-Level Positive Airway Pressure (BIPAP) Versus Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
- ClinicalTrials.gov ID
- NCT01318824
- Acronym / sponsor ID
- BIPAP / 2011002
- Conditions
- Neonatal Respiratory Failure
- Keywords
- Neonatal Respiratory Failure, Newborn Infant, BiPAP, NIPPV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2013 (estimated)
- First posted
- 21 Mar 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.
To research the effect of Bi-Level Positive Airway Pressure (BiPAP) for neonatal respiratory failure.
Detailed description
Bi-Level Positive Airway Pressure(BiPAP) is similar to Non Invasive Positive Pressure Ventilation (NIPPV), but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. BiPAP is safe and effective. Nevertheless, BiPAP has never been used in Chinese babies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I=NIPPV | Placebo comparator | Procedure: Nasal Intermittent Positive Pressure Ventilation (NIPPV)This group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment. |
| II=BiPAP | Experimental | Procedure: Bi-Level Positive Airway Pressure (BIPAP)This group receive Bi-Level Positive Airway Pressure (BIPAP) treatment |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborn infants with birth weight > 500 gm.
- Gestational age > 24 completed weeks.
- Intention to manage the infant with non-invasive respiratory support (i.e. no endotracheal tube), where either: the infant is within the first 7 days of life and has never been intubated or has received less than 24 hours of total cumulative intubated respiratory support the infant is within the first 28 days of life, has been managed with intubated respiratory support for 24 hours or more and is a candidate for extubation followed by non-invasive respiratory support.
- No known lethal congenital anomaly or genetic syndromes.
- Signed parental informed consent.
Key exclusion criteria (6 listed)
- Considered non-viable by clinician (decision not to administer effective therapies)
- Life-threatening congenital abnormalities including congenital heart disease (excluding patent ductus arteriosis)
- Infants known to require surgical treatment
- Abnormalities of the upper and lower airways
- Neuromuscular disorders
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 |
|---|---|---|
| Nasal Intermittent Positive Pressure Ventilation (NIPPV)Also: Nasal Intermittent Positive Pressure VentilationThe Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment | Procedure or surgery | I=NIPPV |
| Bi-Level Positive Airway Pressure (BIPAP)Also: Bi-Level Positive Airway PressureBiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment | Procedure or surgery | II=BiPAP |
Primary outcome
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
Time frame: At 7 days, 28 days and at 36 weeks postmenstraul age
get the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure
1 secondary outcome
the effect of Versus Bi-Level Positive Airway Pressure (BIPAP) for Neonatal Respiratory Failure
Time frame: At 7 days, 28 days and at 36 weeks postmenstraul age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
Related trials for Neonatal Respiratory Failure
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Respiratory Progression in Adults With Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy (DMD), Respiratory Function Decline
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
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.
Yuan Shi, MD study director
Department of Pediatrics, Daping Hospital, Third Military Medical University
Shifang Tang principal investigator
Department of Pediatrics, Daping Hospital, Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nasal Intermittent Positive Pressure Ventilation (NIPPV) and Bi-Level Positive Airway Pressure (BIPAP) in people with Neonatal Respiratory Failure, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Mar 2011. 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 China. 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. 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.
What does this phase mean?
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?
Results are not available in the source record.
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?
the effect of Non Invasive Positive Pressure Ventilation (NIPPV) for Neonatal Respiratory Failure (time frame: At 7 days, 28 days and at 36 weeks postmenstraul age). 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 23 Mar 2011.