Status:
UNKNOWN
Diaphragmatic Electrical Activity in Preterm Infants on Non-Invasive Ventilation
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
Sunnybrook Health Sciences Centre
Conditions:
Respiratory Distress Syndrome, Newborn
Chronic Lung Disease of Newborn (Diagnosis)
Eligibility:
All Genders
48-90 years
Phase:
NA
Brief Summary
Preterm babies have immature lungs and frequent pauses in their breathing which often necessitates breathing support. Nasal Continuous Positive Airway Pressure (CPAP) is one of the most commonly used ...
Detailed Description
Continuous Positive Airway Pressure is one of the most researched and accepted methods of delivering NIV to term and preterm infants. Non-invasive high frequency ventilation is a relatively new method...
Eligibility Criteria
Inclusion
- Clinically stable preterm infants with birth weights ≤1500g admitted to the neonatal intensive care unit (NICU) at the Children's and Women's Hospital of BC
- On nasal continuous positive airway pressure of 6 to 8 cmH20 support for at least 48 hours, treated with methylxanthines for apnea of prematurity and requiring 21-40% of oxygen.
Exclusion
- 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 \>Grade II), neonatal seizure.
- infants with significant congenital heart disease (including symptomatic PDA).
- infants with congenital anomalies of the diaphragm.
- infants 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.
- infants on nasal CPAP and requiring more than 40% oxygen
- infants with significant gastric residuals and vomiting.
- infants with facial anomalies.
- infants with pneumothorax or pneumomediastinum.
- infants in the immediate postoperative period.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03422549
Start Date
July 1 2018
End Date
February 1 2020
Last Update
April 17 2019
Active Locations (1)
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1
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, Canada, V6H 3N1