Recruiting

nCPAP vs. RAM Cannula

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT03121781

Conditions

Preterm Infants

Respiratory Distress Syndrome

CPAP

RAM Cannula

Diaphragm Electrical Activity

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

respiratory support- interface

respiratory support- interface

Study Details

Brief summary:

Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (nCPAP) is one of the most commonly used tools, but the standard interfaces (prongs or mask) may cause nasal-septal injury and discomfort.

The RAM cannula is another interface that consists in soft and curved prongs to avoid this nasal injury, but as the seal is not 100%, suboptimal delivery of airway distending pressure could result if they are used to deliver CPAP, as compared to standard interfaces.

The investigators plan to study very low birth weight preterm babies who are generally well but require some support with their breathing. By inserting a special feeding tube with sensors into the stomach, the investigators can measure the electrical activity of the diaphragm (EAdi), which is an important muscle for breathing. By analyzing EAdi in babies receiving nCPAP either with prongs or ram cannula, the investigators will be able to measure and compare how each method of support affects a baby's breathing. This important study will help us determine the most appropriate breathing support for preterm babies.

Conditions

Preterm Infants

Respiratory Distress Syndrome

CPAP

RAM Cannula

Diaphragm Electrical Activity

Study ID

NCT03121781

Start date

Nov 1, 2016

Status verified date

Apr, 2017

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Dec 31, 2019

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 GA and no recent increase in apneic episodes or spells and confirmed by the attending neonatologist) with birth weights less than 1500 gr and/or gestational age bellow 32 weeks, admitted to the NICU at Sunnybrook Health Sciences Centre on nasal continuous positive airway pressure of 5 to 8 cmH20 support, for at least 48 h and requiring less than 35% of oxygen.

Exclusion Criteria:

  • Infants with congenital anomalies of the gastrointestinal tract, phrenic nerve damage, diaphragmatic paralysis, esophageal perforation; infants with congenital or acquired neurological deficit (including significant intraventricular hemorrhage greater than Grade II), neonatal seizure; infants with significant congenital heart disease (including symptomatic PDA); infant with congenital anomalies of the diaphragm; infant with congenital anomalies of the respiratory tracts (e.g. Congenital Cystic Adenomatoid Malformation (CCAM)) infants requiring ongoing treatment for sepsis, necrotizing enterocolitis (NEC), antibiotics for lung infections, narcotic analgesics, or gastric motility agents will be excluded. Infants on nasal CPAP and requiring more than 35% oxygen will be excluded from the study. Infants with significant gastric residuals and vomiting, infants with facial anomalies, infants with pneumothorax or pneumomediastinum, and infants in the immediate postoperative period will be excluded. Infants with nasal excoriations will be excluded from the study as they may be electively placed on the RAM cannula to prevent further nasal trauma.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CPAP with binasal prongs

Edi will be recorded while the infant is on nasal CPAP with the binasal prongs, with a PEEP of 5-8 cm H2O, for 2 hours. Then, the infant will be switched the interface to the RAM cannula, with a PEEP 2 cmH2O higher, during 2 hours.

active comparator: CPAP with RAM cannula

Edi will be recorded while the infant is on nasal CPAP with the RAM cannula with a PEEP 2 cmH20 higher than the levels the infant was receiving before starting the study protocol, for 2 hours. Then, the infant will be switched the interface to the binasal prongs with a PEEP between 5-8 cmH2O, during 2 hours.

Interventions

respiratory support- interface

change interface to RAM cannula

respiratory support- interface

change interface to binasal prongs

Primary outcome measure

  • Differences in Edi min between CPAP with binasal prongs versus with the RAM cannula [ Time Frame: 4 hours ]

Central Contacts and Locations

Central contacts

Michael Dunn, MD

(416) 480-6100michael.dunn@sunnybrook.ca

Carolina Lopez-Sanguos, MD

6479265754caro_ls4@msn.com

Locations

Sunnybrook Health Science Centre

Recruiting

Toronto, Ontario, Canada, M4N3M5

Contacts

Michael Dunn, MD

(416) 480-6100michael.dunn@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Sep 20, 2018

Last verified

Apr, 2017

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 2018-09-20.