Effect of Continuous Positive Airway Pressure Delivered by Two Different Modalities on Breathing Pattern in Preterm Infants

Effects of Continuous Positive Airway Pressure (CPAP) Delivered by High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure on the Diaphragm Electrical Activity in Very Low Birth Weight Preterm Infants

In this study, the investigators want to observe how continuous positive airway pressure delivered by two different modalities affects breathing pattern in small preterm infants. Using a specialized feeding tube in the stomach, the investigators can measure and compare how the diaphragm (a large breathing muscle) might be affected by those two modalities.

Study Overview

• Status: Completed
• Conditions: Continuous Positive Airway Pressure

Detailed Description

Many preterm very low birth weight infants require continuous positive airway pressure(CPAP) for breathing support because of lung immaturity. CPAP can be delivered by the infant flow(TM) device which is well studied. Prolonged use of nasal prongs CPAP has been shown to cause discomfort and, rarely, nasal injury leading to long term disfigurement. On the other hand, High flow nasal cannula (HFNC) ,which is another modality of delivering CPAP, creates less pressure on the nose and less disfiguring effect but previous research showed that the use of HFNC may be less effective than IF-CPAP in providing breathing support in these infants.

We plan to study 10 stable preterm infants born less than 32 weeks' gestation and 1.5 kilograms at birth after being stable for at least 48hours on IF-CPAP. babies will be randomized to start on IF-CPAP or HFNC for 30 minutes. After 45 minutes of adaptation, baby will be switched to the other modality for another 30 minutes. By inserting a specialized feeding tube with sensors into the stomach, we can measure the electrical activity of the diaphragm (EAdi). By analysing EAdi with each modality of delivering CPAP, we want to directly assess how HFNC affects breathing compared to IF-CPAP.

• Study Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

clinically stable preterm infants with birth weight less than 1.5 kilograms and gestational age less than 32 weeks admitted to the neonatal intensive care unit at Sunnybrook Health Sciences centre on nasal continuos positive airway pressure(CPAP) of 5-6 cmH2O support for at least 48 hours, treated with Methylxanthines for apnea of prematurity and in less than 35% oxygen.

Description

Inclusion Criteria:

• Birth weights ≤ 1500g
• Gestational age less than 32 week
• Stable on nasal continuous positive airway pressure (CPAP) of 5-6cmH20 support for at least 48 hours
• Treated with methylxanthines for apnea of prematurity
• In less than 35% oxygen

Exclusion Criteria:

• Congenital and acquired problem of the gastrointestinal tract
• Phrenic nerve injury and/or diaphragm paralysis
• Esophageal perforation/tracheoesophageal fistula
• Congenital/acquired neurological deficit and/or seizures
• Hemodynamic instability
• Congenital heart disease (including symptomatic patent ductus arteriosus)
• Undergoing treatment for sepsis or pneumonia
• Use of muscle relaxants, narcotic analgesics, or gastric motility agents
• Congenital anomalies of respiratory tract (e.g. CCAM)
• Infants requiring more than 35% oxygen
• Infants with facial anomalies
• Infants with pneumothorax and/or pneumomediatinum
• Infants in the immediate postoperative period
• Infants with significant gastric residues and vomiting

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
EAdi 1; babies in this group will first receive CPAP through IF-CPAP for 30 minutes. After another 45 minutes, they will be switched to HFNC for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.
EAdi 2; babies in this group will first receive CPAP through HFNC for 30 minutes. After another 45 minutes, they will be switched to IF-CPAP for 30 minutes. EAdi will be recorded for the last 15 minutes of each 30 minutes period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The difference in the tonic EAdi between IF-CPAP and HFNC .	Patients will be randomized in two groups, one group will start on IF-CPAP for 30 minutes. After another 45 minutes, this group will be switched to HFNC for another 30 minutes. The other group will start on HFNC and then switched to IF-CPAP. EAdi will be analyzed in the last 15 minutes of each 30 minutes period.	During the 4-hour study period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.		During the 4-hour study period.
Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.		During the 4-hour study period.
Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform.	These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.	During the 4-hour study period.

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: The Physicians' Services Incorporated Foundation
• Investigators: Principal Investigator: Michael Dunn, MD, Sunnybrook Health Sciences Centre; Principal Investigator: Nehad Nasef, M.B.B.Ch, Sunnybrook Health Sciences Centre; Principal Investigator: Maureen Reilly, RRT, Sunnybrook Health Sciences Centre; Principal Investigator: Patti Schurr, RN(EC), Sunnybrook Health Sciences Centre; Principal Investigator: Jennifer Beck, Ph.D., Unity Health Toronto; Study Director: Eugene Ng, MD, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 30, 2011
• First Posted (Estimate): March 31, 2011

Study Record Updates

• Last Update Posted (Estimate): June 18, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: apnea; continuous positive airway pressure; diaphragm; infant, premature; infant, very low birth weight
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: 254-2010