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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Sunnybrook Health Sciences Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01326975
First received: March 23, 2011
Last updated: March 30, 2011
Last verified: February 2011
  Purpose

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.


Condition
Continuous Positive Airway Pressure

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • The difference in the tonic EAdi between IF-CPAP and HFNC . [ Time Frame: During the 4-hour study period. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Difference in the number of apnea episodes (breathing pauses) on EAdi recorded with each modality. [ Time Frame: During the 4-hour study period. ] [ Designated as safety issue: No ]
  • Difference in episodes of clinically significant apnea with HFNC and IF-CPAP. [ Time Frame: During the 4-hour study period. ] [ Designated as safety issue: No ]
  • Indices of respiratory muscle effort (inspiratory and expiratory) will be calculated from Edi waveform. [ Time Frame: During the 4-hour study period. ] [ Designated as safety issue: No ]
    These indices include the phasic Edi to the peak, mean inspiratory Edi, Edi-time product, post inspiratory activity and all neural timings.


Estimated Enrollment: 10
Study Start Date: May 2011
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326975

Contacts
Contact: Patti Schurr, RN (EC) 416-480-6100 ext 87986 patti.schurr@sunnybrook.ca
Contact: Eugene Ng, MD 416-480-6100 ext 87781 eugene.ng@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada
Contact: Eugene Ng, MD    416-480-6400 ext 87781    eugene.ng@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
The Physicians' Services Incorporated Foundation
Investigators
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: Michael Dunn, MD Sunnybrook Health Sciences Centre
Principal Investigator: Jennifer Beck, Ph.D. St. Michael's Hospital, Toronto
Study Director: Eugene Ng, MD Sunnybrook Health Sciences Centre
  More Information

No publications provided

Responsible Party: Eugene Ng, MD, FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01326975     History of Changes
Other Study ID Numbers: 254-2010
Study First Received: March 23, 2011
Last Updated: March 30, 2011
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
infant, premature
infant, very low birth weight
diaphragm
apnea
continuous positive airway pressure

ClinicalTrials.gov processed this record on October 20, 2014