CPAP vs NIPPV for Premature Infants

Recruiting in Palo Alto (17 mi)

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Narcotic analgesics, Gastric motility agents

Disqualifiers: Congenital anomalies, Sepsis, NEC, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the treatment Edi Signal Measurement, Diaphragm Electrical Activity Measurement for premature infants?

The research suggests that measuring the electrical activity of the diaphragm (Edi) can help compare the effectiveness of different breathing support methods like CPAP and NIPPV in premature infants. This measurement may provide insights into how well these treatments support breathing in preterm babies. ^{1 2 3 4 5}

Is CPAP or NIPPV safe for premature infants?

Studies have shown that both CPAP and NIPPV are generally safe for premature infants, with some research indicating that NIPPV may be more effective in certain cases. Safety concerns like feed intolerance, necrotizing enterocolitis (a serious intestinal disease), and other conditions were monitored, but no significant safety issues were highlighted in the studies. ^{1 2 3 4 6}

How does Edi Signal Measurement differ from other treatments for premature infants?

Edi Signal Measurement is unique because it monitors the electrical activity of the diaphragm, helping to tailor respiratory support to the infant's natural breathing efforts, unlike CPAP or NIPPV which provide constant or intermittent pressure without this personalized adjustment. ^{1 2 3 4 7}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Edi Signal Measurement (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Sunnybrook Health Sciences Center Toronto, Canada

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre Lead Sponsor

References

1. United States 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. [2020] To compare the electrical activity of the diaphragm (Edi) of premature infants placed on continuous positive airway pressure (CPAP) with the Edi of premature infants placed on noninvasive neurally adjusted ventilatory assist (NIV NAVA). The secondary aim was to evaluate the feasibility of the use of NIV NAVA mode in the busy tertiary neonatal unit.

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of High CPAP versus NIPPV in Preterm Neonates: A Retrospective Cohort Study. [2023] The aim of this study was to compare outcomes following receipt of high continuous positive airway pressure (CPAP) versus nasal intermittent positive pressure ventilation (NIPPV) in extremely preterm neonates.

3. United States 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. [2023] Continuous positive airway pressure (CPAP) is a standard respiratory care for neonates for last few decades but it too has a high failure rate. Nasal intermittent positive pressure ventilation (NIPPV) is proven to be superior to CPAP in maintaining higher mean airway pressure in neonates with Respiratory Distress Syndrome. The main objective of this study was to compare failure within 72 h of initiation of primary respiratory support between nonsynchronized NIPPV and CPAP in all causes of respiratory distress in newborn infants. Secondarily feed intolerance, Necrotizing enterocolitis (NEC > stage II), hemodynamically significant patent ductus arteriosus, intraventricular hemorrhage (IVH > gradeIII), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), duration of support and mortality were also compared.

4. Norway pubmed.ncbi.nlm.nih.gov

Early nasal intermittent positive pressure ventilation versus continuous positive airway pressure for respiratory distress syndrome. [2022] To determine whether early nasal intermittent positive pressure ventilation (NIPPV), in comparison to early continuous positive airway pressure (CPAP), can reduce the need for intubation and mechanical ventilation in preterm neonates with suspected respiratory distress syndrome (RDS).

5. England pubmed.ncbi.nlm.nih.gov

Diaphragm electrical activity during weaning of nasal high-flow therapy in preterm infants. [2023] To determine whether electrical activity of the diaphragm (Edi) changes with weaning nasal high-flow (HF) therapy in preterm infants according to a standardised protocol.

6. England pubmed.ncbi.nlm.nih.gov

Continuous neurally adjusted ventilation: a feasibility study in preterm infants. [2020] To assess the feasibility and tolerance of NeuroPAP, a new non-invasive ventilation mode which continuously adjusts (during both inspiration and expiration) the pressure support proportionally to the diaphragm electrical activity (Edi), in preterm infants and to evaluate the impact on ventilation pressure and Edi.

7. Norway pubmed.ncbi.nlm.nih.gov

A randomised cross-over study showed no difference in diaphragm activity during weaning from respiratory support. [2019] We measured electrical activity of the diaphragm (Edi) to compare the breathing effort in preterm infants during weaning from respiratory support with high-flow nasal cannulae (HFNC) or nasal continuous positive airway pressure (nCPAP).