Preterm BirthNCT06295484
Effect of Nasal CPAP Versus NIPPV On Diaphragm Electrical Activity (Edi) In VLBW Preterm Infants
A study testing Alternating traditional CPAP, NIPPV, and high CPAP in people with Preterm Birth and Premature Lungs, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Background: In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. Read more about this study
- Who is it for?
- Ages 1 day to 8 months
- Conditions the study is for
- Preterm Birth, Premature Lungs, Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Alternating traditional CPAP, NIPPV, and high CPAP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 21 Aug 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)
- Birth weight less than 1500 grams
- Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen
Who cannot join
- Congenital anomalies of the gastrointestinal tract
- Phrenic nerve damage
- Diaphragmatic paralysis
- Esophageal perforation
- Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure
- Significant congenital heart disease (including symptomatic PDA)
Show all 18Show fewer
- Congenital anomalies of the diaphragm
- Congenital anomalies of the respiratory tracts (e.g., Congenital Cystic Adenomatoid Malformation 'CCAM')
- Ongoing treatment for sepsis
- Ongoing treatment for necrotizing enterocolitis (NEC)
- Ongoing treatment for lung infections
- Narcotic analgesics
- Gastric motility agents
- Infants on nasal CPAP and requiring more than 35% oxygen
- Infants with significant gastric residuals and vomiting
- Infants with facial anomalies
- Infants with pneumothorax or pneumomediastinum
- Infants in the immediate postoperative period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
Maher Shahroor, MD, (416) 480-6100 ext. 687939, maher.shahroor@sunnybrook.ca
About this study
Official title: Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants
Background:
In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.
Read more
The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.
Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.
One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.
Read the detailed description
Our main goal in this study:
To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV.
Inclusion Criteria (Potential Candidates):
This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP.
The steps of the study:
The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. The investigators will continue to record the Edi signals during the 3 methods.
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, the participant's baby will be put back to the originally prescribed breathing support.
Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.
- Being tested
- Alternating traditional CPAP, NIPPV, and high CPAP
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating traditional CPAP, NIPPV, and high CPAPOther
The investigators will continue to record the Edi signals during the 3 methods (traditional CPAP, NIPPV, and high CPAP)
| Study group | Role | What they receive |
|---|---|---|
| Traditional CPAP, then NIPPV, then high CPAP. | Other | The participant will stay for 2 hours on Traditional CPAP, then 2 hours on NIPPV, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
| Traditional CPAP, then high CPAP, then NIPPV | Other | The participant will stay for 2 hours on Traditional CPAP, then 2 hours on high CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
| NIPPV, then traditional CPAP, then high CPAP | Other | The participant will stay for 2 hours on NIPPV, then 2 hours on traditional CPAP, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
| NIPPV, then high CPAP, then traditional CPAP. | Other | The participant will stay for 2 hours on NIPPV, then 2 hours on high CPAP, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
| High CPAP, then traditional CPAP, then NIPPV. | Other | The participant will stay for 2 hours on High CPAP, then 2 hours on traditional CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
| High CPAP, then NIPPV, then traditional CPAP. | Other | The participant will stay for 2 hours on High CPAP, then 2 hours on NIPPV, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods. Receives: Other: Alternating traditional CPAP, NIPPV, and high CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O).
Measured: 2 hours per each mode of ventilation, total of 6 hours Edi recording
Secondary outcomes (4)
1. Neural respiratory rate per minute
Measured: 2 hours per each mode of ventilation, total of 6 hours
2. Edi peak measured in MicroVoltage
Measured: 2 hours per each mode of ventilation, total of 6 hours
3. The difference in transcutaneous pCO2 in mmHg
Measured: 2 hours per each mode of ventilation, total of 6 hours
4. The difference in oxygen requirements in percent (i.e, 21%)
Measured: 2 hours per each mode of ventilation, total of 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start21 Aug 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods. Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support. Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295484
- Sponsor's protocol ID
- 5136
- Status last verified
- Feb 2024
- First submitted
- 20 Feb 2024
- Last updated
- 6 Mar 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nasal Continuous Positive Airway Pressure (nCPAP) Versus Non-Invasive Positive Pressure Ventilation (NIPPV) On Diaphragm Electrical Activity (Edi) In Very Low Birth Weight (VLBW) Preterm Infants
- ClinicalTrials.gov ID
- NCT06295484
- Acronym / sponsor ID
- 5136
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 6 Mar 2024 (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.
Background:
In premature babies, many organ systems are not fully grown and developed, including the lungs and respiratory muscles, so they will need breathing support to help them to breathe by preventing their tiny air sacs to collapse. This support commonly done by CPAP and Non-Invasive Positive Pressure Ventilation (NIPPV) therapy by giving some pressure and oxygen to their lungs through an interface placed on their noses. Both (CPAP and NIPPV) can be used as a support modality for respiratory distress syndrome, apnea of prematurity, and providing breathing support after extubation from the full mechanical breathing support.
The CPAP supports the baby's immature lungs by delivering constant pressure to keep their lungs and breathing well supported. Whereas the NIPPV will use constant pressure in the background (similar to CPAP), and on top, it will give extra intermittent puffs at regular intervals to support the baby's breathing. The NIPPV is the most common choice by the clinicians when the traditional CPAP is no longer effective, to avoid the full mechanical breathing support and to protect the developing lungs.
Studies suggested that NIPPV is better than the traditional CPAP in reducing the need of the baby to need full mechanical breathing support. This might be because the investigators tend to use lower pressures with CPAP (5-8 cmH2O) compared to relatively higher pressures with NIPPV. More recently, clinicians showed the safety of using equivalent higher CPAP pressures (>9 cmH2O) to what the investigators use in the NIPPV in preterm babies.
One way to measure the support that the investigators are giving to the patient with the different devices is to measure the diaphragm activity, which the investigators call the Edi signal, using a special feeding catheter and a specific machine to measure it. The catheter is placed and used as a routine feeding tube but has sensors at the end to measure this Edi signal. One opening of the tube will be connected to a computer to record the Edi signals. The other opening of the tube will be used for feeding.
Detailed description
Our main goal in this study:
To measure and compare the Edi in preterm babies requiring breathing support with CPAP or NIPPV.
Inclusion Criteria (Potential Candidates):
This study involves stable babies who were born with a birth weight of less than 1500 grams and require CPAP.
The steps of the study:
The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. The investigators will continue to record the Edi signals during the 3 methods.
Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, the participant's baby will be put back to the originally prescribed breathing support.
Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- The baby will be assigned to first go on traditional CPAP, NIPPV, or high CPAP, stay for 2 hours, switch to one of the other methods for 2 hours and then spend 2 hours supported by the remaining method. We will continue to record the Edi signals during the 3 methods. Study duration will be 6 hours from the time of catheter insertion to fit into feeding and handling plans. Upon completion or termination of the study protocol, your baby will be put back to the originally prescribed breathing support. Routine monitoring for oxygen saturation, heart rate, and respiratory rate will be continued as per the standard of practice in the NICU.
| Arm | Type | Receives |
|---|---|---|
| Traditional CPAP, then NIPPV, then high CPAP. | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on Traditional CPAP, then 2 hours on NIPPV, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods. |
| Traditional CPAP, then high CPAP, then NIPPV | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on Traditional CPAP, then 2 hours on high CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods. |
| NIPPV, then traditional CPAP, then high CPAP | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on NIPPV, then 2 hours on traditional CPAP, then 2 hours on high CPAP. The investigators will continue to record the Edi signals during the 3 methods. |
| NIPPV, then high CPAP, then traditional CPAP. | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on NIPPV, then 2 hours on high CPAP, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods. |
| High CPAP, then traditional CPAP, then NIPPV. | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on High CPAP, then 2 hours on traditional CPAP, then 2 hours on NIPPV. The investigators will continue to record the Edi signals during the 3 methods. |
| High CPAP, then NIPPV, then traditional CPAP. | Other | Other: Alternating traditional CPAP, NIPPV, and high CPAPThe participant will stay for 2 hours on High CPAP, then 2 hours on NIPPV, then 2 hours on traditional CPAP. The investigators will continue to record the Edi signals during the 3 methods. |
Who may qualify
- Ages
- 1 day to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinically stable preterm infants (defined as cardiovascular stability with normal blood pressure and heart rate for gestational age and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist)
- Birth weight less than 1500 grams
- Admitted to the NICU at Sunnybrook Health Sciences Centre on nasal CPAP of 5 to 8 cmH2O support, for at least 48 hours and requiring less than 35% of oxygen
Key exclusion criteria (18 listed)
- Congenital anomalies of the gastrointestinal tract
- Phrenic nerve damage
- Diaphragmatic paralysis
- Esophageal perforation
- Congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II) or neonatal seizure
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 |
|---|---|---|
| Alternating traditional CPAP, NIPPV, and high CPAPThe investigators will continue to record the Edi signals during the 3 methods (traditional CPAP, NIPPV, and high CPAP) | Other | High CPAP, then NIPPV, then traditional CPAP., High CPAP, then traditional CPAP, then NIPPV., NIPPV, then high CPAP, then traditional CPAP., NIPPV, then traditional CPAP, then high CPAP, Traditional CPAP, then NIPPV, then high CPAP., Traditional CPAP, then high CPAP, then NIPPV |
Primary outcome
The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O).
Time frame: 2 hours per each mode of ventilation, total of 6 hours Edi recording
4 secondary outcomes
1. Neural respiratory rate per minute
Time frame: 2 hours per each mode of ventilation, total of 6 hours
2. Edi peak measured in MicroVoltage
Time frame: 2 hours per each mode of ventilation, total of 6 hours
3. The difference in transcutaneous pCO2 in mmHg
Time frame: 2 hours per each mode of ventilation, total of 6 hours
4. The difference in oxygen requirements in percent (i.e, 21%)
Time frame: 2 hours per each mode of ventilation, total of 6 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating traditional CPAP, NIPPV, and high CPAP in people with Preterm Birth and Premature Lungs, run by Sunnybrook Health Sciences Centre at 1 site 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 3 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 6 Mar 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maher Shahroor, MD ((416) 480-6100 ext. 687939, maher.shahroor@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences in Electrical Activity of the Diaphragm measured in MicroVoltage (Edi minimum) between: 1. Traditional CPAP versus NIPPV. 2. NIPPV versus CPAP (equivalent pressures in cmH2O). (time frame: 2 hours per each mode of ventilation, total of 6 hours Edi recording). 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 6 Mar 2024.