CPAP vs NIPPV for Premature Infants

Overseen By Maher Shahroor, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Narcotic analgesics, Gastric motility agents

Disqualifiers: Congenital anomalies, Sepsis, NEC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 hours

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how two types of breathing support assist premature infants with underdeveloped lungs. It compares traditional CPAP, which delivers constant air pressure, to NIPPV, which adds extra air puffs to aid breathing. The goal is to determine which method more effectively reduces the need for full mechanical ventilation. Babies on CPAP with a birth weight under 1500 grams and requiring less than 35% oxygen may qualify for this study. The trial will also use Edi Signal Measurement (Diaphragm Electrical Activity Measurement) to assess breathing effort. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance care for premature infants.

Will I have to stop taking my current medications?

The trial does not specify if participants must stop taking their current medications, but it excludes infants on certain treatments like narcotic analgesics and gastric motility agents. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both CPAP and NIPPV are generally safe for premature babies. CPAP provides steady air pressure to help keep a baby's lungs open. Studies have found it to be a safe way to help preterm babies breathe better. It doesn't use drugs, making it a good option for supporting lung growth and function without extra risks.

NIPPV is similar but adds extra bursts of air to assist with breathing. This method is also considered safe and has improved oxygen levels and reduced the need for full mechanical support. It can be more effective than CPAP alone, especially when using higher pressures.

In summary, both CPAP and NIPPV have strong safety records for helping premature infants with breathing problems. They are non-invasive, meaning they don't require surgery or insertion into the body, which minimizes risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to compare how different respiratory support methods—High CPAP, traditional CPAP, and NIPPV—impact premature infants. These methods are already used, but the trial seeks to understand how switching between them affects breathing patterns, measured by Edi signals. By evaluating these transitions, researchers hope to find the most effective way to support premature infants' breathing, potentially leading to improved outcomes and personalized care strategies. This could mean better-targeted respiratory support and reduced risks for these vulnerable infants.

What evidence suggests that this trial's treatments could be effective for premature infants?

Research has shown that NIPPV (Non-Invasive Positive Pressure Ventilation) can be more effective than traditional CPAP (Continuous Positive Airway Pressure) for premature babies with breathing problems. Studies have found that NIPPV reduces the need for full mechanical breathing support and lowers the risk of serious lung issues like bronchopulmonary dysplasia (BPD). This may be because NIPPV not only provides continuous pressure but also delivers extra puffs of air, offering more support than CPAP. CPAP, on the other hand, helps by keeping the baby's lungs open with steady pressure, preventing breathing failure. In this trial, participants will experience both NIPPV and CPAP in various sequences to evaluate their effectiveness. In summary, both treatments aid breathing, but NIPPV might offer more protection against further complications. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for very low birth weight preterm infants who need breathing support due to immature lungs. It's not suitable for those with certain medical conditions that the study doesn't specify.

Inclusion Criteria

My baby was born weighing less than 1500 grams and is now stable.

My baby is in the NICU on mild breathing support and needs a little extra oxygen.

Exclusion Criteria

My infant has air trapped in the chest or around the lungs.

My infant is in the period right after surgery.

I have a brain condition from birth or developed one that includes severe bleeding or seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are assigned to different sequences of CPAP and NIPPV for 6 hours to measure diaphragm electrical activity (Edi)

6 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Edi Signal Measurement

Trial Overview The study tests how different non-invasive breathing supports affect diaphragm activity in premature babies. It compares traditional CPAP, NIPPV, and high-pressure CPAP to see which helps their tiny lungs best.

How Is the Trial Designed?

Group I: Traditional CPAP, then high CPAP, then NIPPV Experimental Treatment 1 Intervention

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.

Group II: Traditional CPAP, then NIPPV, then high CPAP. Experimental Treatment 1 Intervention

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.

Group III: NIPPV, then traditional CPAP, then high CPAP Experimental Treatment 1 Intervention

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.

Group IV: NIPPV, then high CPAP, then traditional CPAP. Experimental Treatment 1 Intervention

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.

Group V: High CPAP, then traditional CPAP, then NIPPV. Experimental Treatment 1 Intervention

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.

Group VI: High CPAP, then NIPPV, then traditional CPAP. Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

In a study of 10 premature infants, the electrical activity of the diaphragm (Edi) was significantly lower when using noninvasive neurally adjusted ventilatory assist (NIV NAVA) compared to continuous positive airway pressure (CPAP), suggesting that NIV NAVA may provide less respiratory effort for these infants.

The use of NIV NAVA was found to be safe, with no major adverse events reported during the monitoring period, indicating its feasibility in a busy neonatal unit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical Activity of the Diaphragm in a Small Cohort of Preterm Infants on Noninvasive Neurally Adjusted Ventilatory Assist and Continuous Positive Airway Pressure: A Prospective Comparative Pilot Study. Gupta, A., Lumba, R., Bailey, S., et al.[2020]

In a study involving 21 preterm infants, there was no significant difference in breathing effort, as measured by electrical activity of the diaphragm (Edi), between high-flow nasal cannulae (HFNC) and nasal continuous positive airway pressure (nCPAP).

However, the mean respiratory rate was significantly lower during HFNC compared to nCPAP, suggesting that HFNC may be a suitable alternative for weaning preterm infants from respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. Brenne, H., Grunewaldt, KH., Follestad, T., et al.[2019]

In a study of 40 preterm infants receiving nasal high-flow therapy, a standardized weaning protocol resulted in a 91% success rate for weaning, indicating that this approach is effective and safe.

While the electrical activity of the diaphragm (Edi) did not change significantly during gradual flow reductions, there was a notable increase in diaphragm activity immediately after discontinuing high-flow therapy, suggesting that complete cessation may enhance respiratory muscle engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diaphragm electrical activity during weaning of nasal high-flow therapy in preterm infants. Naples, R., Fenton, AC., Brodlie, M., et al.[2023]

NeuroPAP, a new non-invasive ventilation mode, was found to be feasible and well tolerated in 20 stable preterm infants, allowing for continuous adjustment of pressure support based on diaphragm electrical activity.

During NeuroPAP, 78% of breaths were well synchronized with the infants' breathing efforts, significantly improving patient-ventilator synchrony compared to traditional non-invasive positive pressure ventilation (NIPPV), which had only 9% synchronization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous neurally adjusted ventilation: a feasibility study in preterm infants. Rochon, ME., Lodygensky, G., Tabone, L., et al.[2020]

In a study of 216 neonates with respiratory distress, nonsynchronized nasal intermittent positive pressure ventilation (NIPPV) was found to be significantly more effective than continuous positive airway pressure (CPAP) in preventing the need for intubation within 72 hours of starting treatment.

NIPPV also showed advantages in reducing the duration of noninvasive ventilation, the occurrence of bronchopulmonary dysplasia (BPD), and the length of hospital stay, suggesting it may be a better primary respiratory support option for newborns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsynchronized nasal intermittent positive pressure ventilation versus continuous positive airway pressure as a primary mode of respiratory support in neonates (26-40 weeks) admitted in a tertiary care center: A randomized controlled trial. Dey, R., Sardar, SK., Kumar Saha, A., et al.[2023]

In a study of 172 extremely preterm neonates (22-28 weeks' gestation), high continuous positive airway pressure (CPAP) and nasal intermittent positive pressure ventilation (NIPPV) showed no significant difference in failure rates within 7 days, indicating both methods are similarly effective.

Infants on high CPAP were more likely to require an alternate noninvasive support mode, suggesting that while both methods are effective, high CPAP may lead to a higher need for additional respiratory support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of High CPAP versus NIPPV in Preterm Neonates: A Retrospective Cohort Study. Ahmad, HA., Deekonda, V., Patel, W., et al.[2023]

In a study of 76 preterm neonates with respiratory distress syndrome, early nasal intermittent positive pressure ventilation (NIPPV) significantly reduced the failure rate of respiratory support compared to early continuous positive airway pressure (CPAP), with rates of 13.5% versus 35.9%, respectively.

NIPPV also led to a lower need for intubation and mechanical ventilation within 7 days (18.9% vs. 41%), indicating it may be a more effective intervention for managing respiratory distress in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure for respiratory distress syndrome. Sai Sunil Kishore, M., Dutta, S., Kumar, P.[2022]

Citations

1. atsjournals.org atsjournals.org/doi/full/10.1164/rccm.202411-2169OC

Extended Continuous Positive Airway Pressure in Preterm ... This study demonstrates that extending the duration of nasal bubble CPAP in stable preterm infants can stimulate both their lung and blood ...

2. publications.aap.org publications.aap.org/pediatrics/article/153/4/e2023064045/196902/CPAP-Versus-NIPPV-Postextubation-in-Preterm

CPAP Versus NIPPV Postextubation in Preterm Neonates A total of 843 infants extubated to CPAP and 974 extubated to NIPPV were included. CPAP was not noninferior (and inferior) to NIPPV for failure ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa072788

Nasal CPAP or Intubation at Birth for Very Preterm Infants Infants in the CPAP group had a better outcome at 28 days than did those in the intubation group; the two groups had a similar outcome at 36 weeks' gestational ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0146000524000119

Non-invasive versus invasive respiratory support in ... A non-randomized population-based study including over 19,000 infants found the rate of CPAP failure (need for intubation <72 h) in infants commencing on CPAP ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33058208/

Continuous positive airway pressure (CPAP) for respiratory ... In preterm infants with respiratory distress, the application of CPAP is associated with reduced respiratory failure, use of mechanical ventilation and ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37481707/

Continuous positive airway pressure (CPAP) for apnoea of ... CPAP is a form of non-invasive ventilatory assistance that has been shown to be relatively safe and effective in preventing and treating respiratory distress ...

7. bmcpediatr.biomedcentral.com bmcpediatr.biomedcentral.com/articles/10.1186/s12887-023-04038-6

CPAP failure in the management of preterm neonates with ... Preterm neonates with RDS who fail CPAP are at higher risk for chronic lung disease as well as death. Unfortunately, in low resource settings ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2405857223000797

Practice of continuous positive airway pressure application ... The aim of this study was to assess the practice of continuous positive airway pressure application in neonatal intensive care.