Nasal Intermittent Positive Pressure VentilationNCT03226977
Nasal Intermittent Positive Pressure Ventilation(NIPPV) vs Continuous Positive Airway Pressure for Respiratory Distress Syndrome
A study testing NIPPV and NCPAP in people with Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with… Read more about this study
- Who is it for?
- Ages 5 minutes to 6 hours
- Conditions the study is for
- Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure
- What is being tested?
- NIPPV and NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 30 Jul 2020
- 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 5 minutes to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) is from 26 to 37 weeks;
- Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- RDS Silverman score>5;
- Informed parental consent has been obtained.
Who cannot join
- Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
- Major congenital malformations or complex congenital heart disease;
- Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
- Cardiopulmonary arrest needing prolonged resuscitation;
- Transferred out of the neonatal intensive care unit without treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Pediatrics, Daping Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, 400042
Juan Ma, physician, 18680887330, zoe330@163.com
About this study
Official title: Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications
Read the detailed description
To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.
- Conditions
- Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure
- Being tested
- NIPPV, NCPAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPPVDevice
NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
NCPAPDevice
NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
| Study group | Role | What they receive |
|---|---|---|
| NIPPV | Experimental | NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome Receives: Device: NIPPV |
| NCPAP | Active comparator | NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome Receives: Device: NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation rate
the infant is intubated ventilation
Measured: within 7 days
Secondary outcomes (4)
Intraventricular hemorrhage
the incidence of intraventricular hemorrhage
Measured: within 28 days
bronchopulmonary dysplasia
bronchopulmonary dysplasia was defined according to the National Institutes of Health consensus definition
Measured: at a post-menstrual age of 36 weeks or at discharge
Bayley Scales of Infant Development
scores of Bayley Scales of Infant Development
Measured: at 2 months old and 2 years old
Neonatal necrotizing enterocolitis(NEC)
the incidence of neonatal necrotizing enterocolitis(>stage II);for NEC, Bell staging will be used
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Aug 2017 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal Intermittent Positive Pressure VentilationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 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
- Collaborators
- Guiyang Maternity and Child Health Care Hospital, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Chengdu Women's and Children's Central Hospital, Kunming Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital, Jiulongpo No.1 People's Hospital
- Responsible party
- Principal investigator, Ma Juan, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Investigators
- Shi Yuan, PhD,MD, Study director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226977
- Sponsor's protocol ID
- NIPPV of multicenter
- Status last verified
- Jun 2017
- First submitted
- 12 Jul 2017
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation vs Continuous Positive Airway Pressure for Preterm Infants With Respiratory Distress Syndrome:a Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03226977
- Acronym / sponsor ID
- NIPPV of multicenter
- Conditions
- Nasal Intermittent Positive Pressure Ventilation, Nasal Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Guiyang Maternity and Child Health Care Hospital, Children's Hospital of Chongqing Medical University, Chongqing Maternal and Child Health Hospital, Yan'an Affiliated Hospital of Kunming Medical University, The Children's Hospital of Zhejiang University School of Medicine, Chengdu Women's and Children's Central Hospital, Kunming Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Children's Hospital of Fudan University, Guangdong Women and Children Hospital, Nanjing Children's Hospital, Jiulongpo No.1 People's Hospital
- Study start
- 1 Aug 2017 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 24 Jul 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.
In the past, several studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.The purpose of the present study was to compare NIPPV with NCPAP on the need for endotracheal ventilation and subsequent complications
Detailed description
To this day, early use of noninvasive respiratory support strategies has been suggested to be the most effective pathway to reduce those risks. Nasal continuous positive airway pressure (NCPAP) and nasal intermittent positive pressure ventilation (NIPPV) are two widely used ways of noninvasive ventilation strategies in preterm infant. As compared with invasive ventilation, NCPAP reduces the risks abnormal neurodevelopment. However, there is only 60% success rate of avoiding intubation in the preterm neonate supported with NCPAP. Supplying with an intermittent peak pressure on NCPAP, NIPPV is considered as a strengthened version of NCPAP with increased flow delivery in the upper airway, increased minute volume and functional residual capacity and recruitment of collapsed alveoli, improved stability of the chest wall and reduced asynchrony of thoraco-abdominal movement,which have been proven to be crucial to decrease the incidences of invasive ventilation and death. However, studies have compared the effects between nasal intermittent positive pressure ventilation(NIPPV) and nasal continuous positive airway pressure(NCPAP) on the incidence of intubation in preterm infants, and the results were inconsistent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NIPPV | Experimental | Device: NIPPVNIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome |
| NCPAP | Active comparator | Device: NCPAPNCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome |
Who may qualify
- Ages
- 5 minutes to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational age (GA) is from 26 to 37 weeks;
- Diagnosis of RDS. The diagnosis of respiratory distress syndrome(RDS) will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest X-ray findings;
- RDS Silverman score>5;
- Informed parental consent has been obtained.
Key exclusion criteria (5 listed)
- Severe RDS requiring early intubation according to the American Academy of Pediatrics guidelines for neonatal resuscitation;
- Major congenital malformations or complex congenital heart disease;
- Group B hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage;
- Cardiopulmonary arrest needing prolonged resuscitation;
- Transferred out of the neonatal intensive care unit without treatment.
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 |
|---|---|---|
| NIPPVNIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome | Device | NIPPV |
| NCPAPNCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome | Device | NCPAP |
Primary outcome
intubation rate
Time frame: within 7 days
the infant is intubated ventilation
4 secondary outcomes
Intraventricular hemorrhage
Time frame: within 28 days
bronchopulmonary dysplasia
Time frame: at a post-menstrual age of 36 weeks or at discharge
Bayley Scales of Infant Development
Time frame: at 2 months old and 2 years old
Neonatal necrotizing enterocolitis(NEC)
Time frame: within 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Individual participant dataSharing planned: Undecided
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HFNC vs NIPPV Following Extubation
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HVNI vs NIPPV in Type 2 Respiratory Failure
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Comparison of Continuous Positive Airway Pressure (CPAP) and Non-Invasive Positive Pressure Ventilation (NIPPV) in Preterm Newborns With Respiratory Distress Syndrome.
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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.
Shi Yuan, PhD,MD study director
Daping Hospital and the Research Institute of Surgery of the 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 and NCPAP in people with Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure, 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 4 inclusion and 5 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 24 Jul 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Juan, MD (13508300283, 476679422@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intubation rate (time frame: within 7 days). 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 24 Jul 2017.