Status:
COMPLETED
Diaphragm Electrical Activity of Preterm Infants on nCPAP Versus NIHFV
Lead Sponsor:
Sunnybrook Health Sciences Centre
Conditions:
Respiratory Distress Syndrome, Newborn
Eligibility:
All Genders
2-60 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 (nCPAP) 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 Sunnybrook Health Sciences Centre or BC Women's and Children's Hospital.
- Patient's 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 25-40% 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) \[27\], neonatal seizure;
- infants with significant congenital heart disease (including symptomatic PDA);
- infant with congenital anomalies of the diaphragm;
- infant 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 will be excluded.
- infants on nasal CPAP and requiring more than 40% oxygen will be excluded from the study.
- infants with significant gastric residuals and vomiting, infants with facial anomalies, infants with pneumothorax or pneumomediastinum, and infants in the immediate postoperative period will be excluded.
Key Trial Info
Start Date :
August 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02267018
Start Date
August 1 2016
End Date
June 30 2020
Last Update
March 17 2021
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5