Back to results

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

Primary Purpose

Preterm Infants, Respiratory Distress Syndrome, CPAP

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

respiratory support- interface

About this trial

This is an interventional treatment trial for Preterm Infants

Eligibility Criteria

23 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sunnybrook Health Science CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

CPAP with binasal prongs

CPAP with RAM cannula

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Difference in neural respiratory rate

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

Difference in neural inspiratory time

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

Difference in Edi peak

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

Difference in transcutaneous pCO2

Measured difference in transcutaneous pCO2 between the 2 different respiratory support modes(nCPAP with binasal prongs and RAM cannula).

Difference in number of apnea episodes

Difference in number of apnea episodes between the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).

Needs of oxygen

Needs of O2 measured by FiO2 on the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).

Full Information

NCT ID

NCT03121781

First Posted

April 17, 2017

Last Updated

September 19, 2018

Sponsor

Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT03121781

Brief Title

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

Official Title

Effect of Nasal Continuous Positive Airway Pressure (nCPAP) With RAM Cannula Versus Standard Binasal Prongs on Diaphragm Electrical Activity in Very Low Birth Weight (VLBW) Preterm Infants

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2016 (Actual)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Different interfaces have been used, most frequently binasal prongs or mask. The RAM cannula is a relatively new interface for delivering CPAP in preterm infants, specially to avoid nasal injury and discomfort. However, there are few studies in artificial models with different results in term of the percentage of pressure that is really delivered when we use the RAM cannula. The objective of this study is to to investigate in VLBW preterm infants who require respiratory support by nasal CPAP, whether or not using the RAM cannula as the interface will allow to provide the level of respiratory support equivalent to that with the traditional binasal prongs, measured by diaphragm electrical activity (Edi). The investigators hypothesize that in VLBW preterm infants with respiratory distress syndrome (RDS), the use of CPAP with RAM cannula as the interface may provide lower PEEP (positive end expiratory pressure) than set and increased resistance to gas flow, leading to increased respiratory effort for the patient as reflected by an increase in Edi. This study will help Neonatologist determine if the amount of support provided with the RAM cannula as interface is equivalent to the support we achieve with the standard interfaces, to select the patients that could benefit from using this interface. The investigators will be able to utilize this information to decide on the most appropriate respiratory support modality for preterm patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Preterm Infants, Respiratory Distress Syndrome, CPAP, RAM Cannula, Diaphragm Electrical Activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CPAP with binasal prongs

Arm Type

Active Comparator

Arm Description

Arm Title

CPAP with RAM cannula

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

respiratory support- interface

Intervention Description

change interface to RAM cannula

Intervention Type

Other

Intervention Name(s)

respiratory support- interface

Intervention Description

change interface to binasal prongs

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 hours

Secondary Outcome Measure Information:

Title

Difference in neural respiratory rate

Description

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

Time Frame

4 hours

Title

Difference in neural inspiratory time

Description

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

Time Frame

4 hours

Title

Difference in Edi peak

Description

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

Time Frame

4 hours

Title

Difference in transcutaneous pCO2

Description

Measured difference in transcutaneous pCO2 between the 2 different respiratory support modes(nCPAP with binasal prongs and RAM cannula).

Time Frame

4 hours

Title

Difference in number of apnea episodes

Description

Difference in number of apnea episodes between the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).

Time Frame

4 hours

Title

Needs of oxygen

Description

Needs of O2 measured by FiO2 on the 2 different respiratory support modes (nCPAP with binasal prongs and RAM cannula).

Time Frame

4 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

23 Weeks

Maximum Age & Unit of Time

32 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michael Dunn, MD

Phone

(416) 480-6100

Ext

87777

michael.dunn@sunnybrook.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Carolina Lopez-Sanguos, MD

Phone

6479265754

caro_ls4@msn.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Dunn, MD

Organizational Affiliation

Staff Neonatologist - NICU

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Science Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N3M5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Dunn, MD

Phone

(416) 480-6100

Ext

87777

michael.dunn@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs