Recruiting

Nasal CPAP vs. NIPPV

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06295484

Conditions

Preterm Birth

Premature Lungs

Respiratory Distress Syndrome in Premature Infant

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Alternating traditional CPAP, NIPPV, and high CPAP

Study Details

Brief 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. 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.

Conditions

Preterm Birth

Premature Lungs

Respiratory Distress Syndrome in Premature Infant

Study ID

NCT06295484

Start date

Aug 21, 2021

Status verified date

Feb, 2024

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Traditional CPAP, then NIPPV, then high CPAP.

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.

other: Traditional CPAP, then high CPAP, then NIPPV

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.

other: NIPPV, then traditional CPAP, then high CPAP

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.

other: NIPPV, then high CPAP, then traditional CPAP.

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.

other: High CPAP, then traditional CPAP, then NIPPV.

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.

other: High CPAP, then NIPPV, then traditional CPAP.

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.

Interventions

Alternating traditional CPAP, NIPPV, and high CPAP

The investigators will continue to record the Edi signals during the 3 methods (traditional CPAP, NIPPV, and high CPAP)

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 ]

Central Contacts and Locations

Central contacts

Maher Shahroor, MD

(416) 480-6100maher.shahroor@sunnybrook.ca

Locations

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Maher Shahroor, MD

(416) 480-6100maher.shahroor@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 6, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2024-03-06.