Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-25 @ 5:03 AM
NCT ID:
NCT02267018
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Days
Maximum Age:
60 Days
Study:
NCT02267018
Study Brief:
Protocol Section:
NCT02267018