CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure (NICA)
Prematurity, Respiratory Distress Syndrome, Apnea of Prematurity
About this trial
This is an interventional treatment trial for Prematurity focused on measuring Continuous positive airway pressure, Nasal intermittent positive pressure ventilation, Mean airway pressure, Apnea, Bradycardia, Prematurity
Eligibility Criteria
Inclusion Criteria:
- Gestational Age 23-34 completed weeks
- Stable on non- invasive respiratory support for at least 24h
- CPAP level of 7-12 cmH2O or NIPPV with MAP 7-12 cmH2O
- FiO2 requirement of <0.40
Exclusion Criteria:
- Clinical instability as judged by the clinical team
- FiO2 requirement of > 0.40 for more than 60 min.
- >10 apnea/bradycardia/desaturation events in past 24 h requiring moderate or vigorous stimulation.
- Anticipated intubation within next 24 h.
- Active abdominal pathology (Spontaneous Intestinal Perforation, confirmed or suspected Necrotizing Enterocolitis, bowel obstruction).
- Hemodynamically significant patent ductus arteriosus (PDA)
- Anticipated weaning off non-invasive support in the next 24 h.
- Any major congenital anomalies, congenital heart disease (other than PDA, atrial septal defect or ventricular septal defect) and cardiac arrhythmias
- Lack of study equipment or personnel
- Lack of parental consent
Sites / Locations
- Women and Infants Hospital of Rhode IslandRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
CPAP first
NIPPV first
The intervention is application of continuous positive airway pressure (CPAP). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.
The intervention is application of nasal intermittent positive pressure ventilation (NIPPV). The order of the two interventions of this crossover study is randomized but each subject will be exposed to both interventions. The period of CPAP will be compared to the period of NIPPV.