PrematurityNICANCT03670732
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
A study testing continuous positive airway pressure and nasal intermittent positive pressure ventilation in people with Prematurity and Respiratory Distress Syndrome, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
Trial summary
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity
- What is being tested?
- continuous positive airway pressure and nasal intermittent positive pressure ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2017to 30 Jun 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational Age 23-34 completed weeks
- Stable on non- invasive respiratory support for at least 24h
- CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O
- FiO2 requirement of <0.40
Who cannot join
- Clinical instability as judged by the clinical team
- FiO2 requirement of > 0.40 for more than 60 min.
- >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.
- Anticipated intubation within next 24 h.
- Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).
- Hemodynamically significant patent ductus arteriosus (PDA)
Show all 10Show fewer
- Anticipated weaning off non-invasive support in the next 24 h.
- Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias
- Lack of study equipment or personnel
- Lack of parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
About this study
Official title: Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.
Read the detailed description
This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants < 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.
- Being tested
- continuous positive airway pressure, nasal intermittent positive pressure ventilation
- Keywords
- Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Apnea, Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous positive airway pressureOther
Also called CPAP
Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
nasal intermittent positive pressure ventilationOther
Also called NIPPV
NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
| Study group | Role | What they receive |
|---|---|---|
| CPAP first | Active comparator | The intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV. Receives: Other: continuous positive airway pressure; Other: nasal intermittent positive pressure ventilation |
| NIPPV first | Active comparator | The intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV. Receives: Other: continuous positive airway pressure; Other: nasal intermittent positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Apnea/bradycardia events
Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor
Measured: Duration of intervention (12 hours)
Secondary outcomes (8)
Number of of desaturation events
Number of episodes of pulse oximetry readings that trigger alarm on the bedside monitor
Measured: Duration of intervention (12 hours)
Mean oxygen saturation by pulse oximetry and proportion of time below 88%
Mean oxygen saturation by pulse oximetry and proportion of time at saturation <88%
Measured: Duration of intervention (12 hours)
Mean transcutaneous PCO2 and proportion of time >55 torr
Mean transcutaneous PCO2 and proportion of time at PCO2 > 55 torr
Measured: Duration of intervention (12 hours)
Mean fraction of inspired oxygen
Mean fraction of inspired oxygen (FIO2)
Measured: Duration of intervention (12 hours)
Mean respiratory rate
Mean respiratory rate
Measured: Duration of intervention (12 hours)
Mean degrees of phase lag by RIP
Estimate of work of breathing based on phase angle as determined by respiratory inductive plethysmography
Measured: Duration of intervention (12 hours)
Number of episodes of feeding intolerance
number of instances of interruption of feeding, abdominal radiographs
Measured: Duration of intervention (12 hours)
Instances of treatment failure
Inability to tolerate assigned treatment by pre-defined criteria
Measured: Duration of intervention (12 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start30 Sep 2017
- Primary completion30 Mar 2020
- Study completion30 Jun 2020
Why it stopped: Unable to obtain needed equipment and COVID-related suspension of clinical research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Crossover
- Model description
- Crossover non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Keszler, Women and Infants Hospital of Rhode Island
- Investigators
- Martin Keszler, MD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670732
- Sponsor's protocol ID
- 1010049
- Other IDs
- WIH 17-0037
- Acronym
- NICA
- Status last verified
- Jul 2024
- First submitted
- 12 Sep 2018
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.
- ClinicalTrials.gov ID
- NCT03670732
- Acronym / sponsor ID
- NICA / 1010049
- Keywords
- Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to obtain needed equipment and COVID-related suspension of clinical research
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 14 Sep 2018 (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.
This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.
Detailed description
This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants < 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| CPAP first | Active comparator | Other: continuous positive airway pressure, Other: nasal intermittent positive pressure ventilationThe intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV. |
| NIPPV first | Active comparator | Other: continuous positive airway pressure, Other: nasal intermittent positive pressure ventilationThe intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV. |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Gestational Age 23-34 completed weeks
- Stable on non- invasive respiratory support for at least 24h
- CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O
- FiO2 requirement of <0.40
Key exclusion criteria (10 listed)
- Clinical instability as judged by the clinical team
- FiO2 requirement of > 0.40 for more than 60 min.
- >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.
- Anticipated intubation within next 24 h.
- Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).
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 |
|---|---|---|
| continuous positive airway pressureAlso: CPAPContinuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study | Other | CPAP first, NIPPV first |
| nasal intermittent positive pressure ventilationAlso: NIPPVNIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study | Other | CPAP first, NIPPV first |
Primary outcome
Number of Apnea/bradycardia events
Time frame: Duration of intervention (12 hours)
Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor
8 secondary outcomes
Number of of desaturation events
Time frame: Duration of intervention (12 hours)
Mean oxygen saturation by pulse oximetry and proportion of time below 88%
Time frame: Duration of intervention (12 hours)
Mean transcutaneous PCO2 and proportion of time >55 torr
Time frame: Duration of intervention (12 hours)
Mean fraction of inspired oxygen
Time frame: Duration of intervention (12 hours)
Mean respiratory rate
Time frame: Duration of intervention (12 hours)
Mean degrees of phase lag by RIP
Time frame: Duration of intervention (12 hours)
Number of episodes of feeding intolerance
Time frame: Duration of intervention (12 hours)
Instances of treatment failure
Time frame: Duration of intervention (12 hours)
Results and safety
The study was stopped early (reason given: Unable to obtain needed equipment and COVID-related suspension of clinical research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Prematurity
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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.
Martin Keszler, MD principal investigator
Brown 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 continuous positive airway pressure and nasal intermittent positive pressure ventilation in people with Prematurity and Respiratory Distress Syndrome, run by Women and Infants Hospital of Rhode Island at 1 site in United States.
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 10 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: stopped early, as of the sponsor's last update on 30 Jul 2024. 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 United States. 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 was stopped early (reason given: Unable to obtain needed equipment and COVID-related suspension of clinical research). 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?
Number of Apnea/bradycardia events (time frame: Duration of intervention (12 hours)). 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 30 Jul 2024.