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

Continuous Positive Airway Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01326975
• Other study ID #: 254-2010
• Status: Completed
• Phase: N/A
• First received: March 23, 2011
• Last updated: June 16, 2015
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Continuous Positive Airway Pressure

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality.		During the 4-hour study period.	No
Secondary	Difference in episodes of clinically significant apnea with HFNC and IF-CPAP.		During the 4-hour study period.	No
Secondary	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.	No