Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula

NCT03121781 | Unknown

• 1 other identifier: RAM cannula study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Differences in Edi min between CPAP with binasal prongs versus with the RAM cannula

  Measured by the electrical activity of the diaphragm between respiratory support modes (nCPAP with binasal prongs and RAM cannula)

  4 hours

Secondary Outcomes (6)

• Difference in neural respiratory rate

  4 hours

• Difference in neural inspiratory time

  4 hours

• Difference in Edi peak

  4 hours

• Difference in transcutaneous pCO2

  4 hours

• Difference in number of apnea episodes

  4 hours

Study Arms (2)

CPAP with binasal prongs

ACTIVE COMPARATOR

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.

Other: respiratory support- interface

CPAP with RAM cannula

ACTIVE COMPARATOR

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.

Other: respiratory support- interface

Interventions

respiratory support- interface OTHER

change interface to RAM cannula

CPAP with binasal prongs

Eligibility Criteria

• Age: 23 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Science Centre

Toronto, Ontario, M4N3M5, Canada

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Michael Dunn, MD

  Staff Neonatologist - NICU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Dunn, MD

CONTACT

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

Carolina Lopez-Sanguos, MD

CONTACT

6479265754; caro_ls4@msn.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization will be done by sealed envelopes, ready for use once consent is obtained.Each envelope will contain a card with the assigned treatment group: protocol 1 or protocol 2. Protocol 1: we start the study on 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. Protocol 2: we start the study on 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.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: April 20, 2017
• Study Start: November 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 20, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)