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

NCT01326975 | Completed DMC

• 1 other identifier: 254-2010
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Continuous Positive Airway Pressure

Keywords

infant, premature; infant, very low birth weight; diaphragm; apnea; continuous positive airway pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

  During the 4-hour study period.

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Days - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• The Physicians' Services Incorporated Foundation: collaborator

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Premature Birth; Apnea

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• 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.

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Eugene Ng, MD

  Sunnybrook Health Sciences Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 31, 2011
• Study Start: May 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 18, 2015

Record last verified: 2015-06

Locations

CA (1)