Respiratory Distress SyndromeNCT00780624
Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
A study testing NIPPV in people with Respiratory Distress Syndrome, run by Third Military Medical University at 1 site in China.
Trial summary
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome
- What is being tested?
- NIPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2012
- 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 1 minute 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: 1) 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; 2)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
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Read the detailed description
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
- Conditions
- Respiratory Distress Syndrome
- Being tested
- NIPPV
- Keywords
- RDS, Infant, newborn, NIPPV, CPAP
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVDevice
Ventilator is Bird VIP.
NIPPVDevice
Ventilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group.
NIPPVDevice
Ventilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition.
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Active comparator | The NIPPV group receiving NIPPV treatment. Receives: Device: NIPPV |
| Control | Active comparator | The Control group receiving nCPAP treatment. Receives: Device: NIPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
Measured: At 7 days after non-invasive respiratorynsupport.
Secondary outcomes (1)
Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.
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 posted27 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2011
- Study completionDec 2012
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 Respiratory Distress SyndromeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan Shi, Third Military Medical University
- Investigators
- Yuan Shi, MD, Study director, Department of Pediatrics, Daping Hospital, Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780624
- Sponsor's protocol ID
- NCR2008053
- Status last verified
- Apr 2016
- First submitted
- 24 Oct 2008
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.
PubMed 24039148
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation In Newborn Infants With Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00780624
- Acronym / sponsor ID
- NCR2008053
- Conditions
- Respiratory Distress Syndrome
- Keywords
- RDS, Infant, newborn, NIPPV, CPAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Oct 2008 (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.
The submitted trial is the first prospective, randomized trial comparing nasal intermittent positive pressure ventilation(NIPPV) vs nCPAP in newborn infants with respiratory distress syndrome.
Detailed description
Nasal intermittent positive pressure ventilation (NIPPV) is similar to nCPAP, but also gives some breaths, or extra support, to newborn infants through a small tube in the nose. NIPPV is safe and effective, and already in use as an alternate "standard" therapy. Nevertheless, NIPPV has never been used in chinese babies.
The submitted trial is the first prospective, randomized trial Comparing NIPPV vs nCPAP in newborn infants with respiratory distress syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Active comparator | Device: NIPPVThe NIPPV group receiving NIPPV treatment. |
| Control | Active comparator | Device: NIPPVThe Control group receiving nCPAP treatment. |
Who may qualify
- Ages
- 1 minute 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: 1) 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; 2)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 |
|---|---|---|
| NIPPVVentilator is Bird VIP. | Device | Control, NIPPV |
| NIPPVVentilator(Bird VIP) is used for NIPPV device. Non-invasive NIPPV is used in the NIPPV group instead of nCPAP in the control group. | Device | Control, NIPPV |
| NIPPVVentilator (Bird VIP, USA) is used for provide of NIPPV in the NIPPV group instead of nCPAP in the control group. The duration of NIPPV is according to the baby's respiratory condition. | Device | Control, NIPPV |
Primary outcome
Incidence of Mechanical Ventilation via endotracheal tube after non-invasive respiratory support.
Time frame: At 7 days after non-invasive respiratorynsupport.
1 secondary outcome
Overall clinical outcomes at 7 days, 28 days, and 36 weeks postmenstrual age.
Time frame: At 7 days, 28 days and at 36 weeks postmenstraul 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 21 Apr 2016.
- Derived from this study: PubMed 24039148Shi Y, Tang S, Zhao J, Shen J. A prospective, randomized, controlled study of NIPPV versus nCPAP in preterm and term infants with respiratory distress syndrome. Pediatr Pulmonol. 2014 Jul;49(7):673-8. doi: 10.1002/ppul.22883. Epub 2013 Sep 4.
- Individual participant dataSharing planned: Undecided
Related trials for Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIPPV in people with Respiratory Distress Syndrome, run by 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: finished, as of the sponsor's last update on 21 Apr 2016. 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. 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 Mechanical Ventilation via endotracheal tube after non-invasive respiratory support. (time frame: At 7 days after non-invasive respiratorynsupport.). 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 NCT00780624, 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 21 Apr 2016.