Clinical trial NCT03670732: CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
Official title: Nasal Intermittent Positive Pressure Ventilation vs. Nasal Continuous Positive Airway Pressure at Equivalent Mean Airway Pressure in Preterm Infants: Effect on Oxygenation, CO2 Elimination, Work of Breathing and Frequency of Cardio-respiratory Events.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prematurity
Respiratory Distress Syndrome
Apnea of Prematurity
Keywords: Continuous positive airway pressure
Nasal intermittent positive pressure ventilation
Mean airway pressure
Apnea
Bradycardia
Prematurity
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 52
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover non-inferiority trial
Primary purpose: TREATMENT

Brief summary: This study seeks to determine if standard continuous positive airway pressure, known as CPAP is as effective as a more complicated approach that generates intermittent increases in airway pressure applied to the nostrils via a breathing machine. The latter is known as NIPPV and requires costly equipment to operate. Previous studies did not ensure that the average pressure applied to the lungs was equal and thus did not make for a fair comparison. The investigators believe that when the same average pressure is applied with the two techniques, CPAP is just as effective as NIPPV and may have fewer side effects, such as blowing air into the stomach. Each baby will receive CPAP or NIPPV in a random sequence for a period of 12 hours, followed by 12 hours on the alternate technique.

Detailed description: This is a pilot clinical trial to evaluate the comparative effectiveness of two commonly used types of non-invasive respiratory support. Preterm infants \< 34 weeks gestational age, who are stable on either of the two modalities of support will be studied in a cross-over study design, such that each subject acts as his/her own control. The study will assess the relative efficacy of these modalities when used with equal mean airway pressure comparing measures of oxygenation, CO2 removal, apnea/bradycardia/desaturation events and work of breathing. The initial phase of the study is complete and preliminary analysis supports the hypothesis that there is no difference between the modalities when the mean airway pressure is equal. However we recognized that use of the RAM cannula, which does not transmit pressure effectively is an important study limitation. The findings are valid, but may only be applicable to this interface, which is widely used, but increasingly recognized as flawed. We are now extending the study to determine if the findings will be the same when short bi-nasal prongs are used.

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

Primary outcomes:
measure: Number of Apnea/bradycardia events
timeFrame: Duration of intervention (12 hours)
Secondary outcomes:
measure: Number of of desaturation events
timeFrame: Duration of intervention (12 hours)
measure: Mean oxygen saturation by pulse oximetry and proportion of time below 88%
timeFrame: Duration of intervention (12 hours)
measure: Mean transcutaneous PCO2 and proportion of time >55 torr
timeFrame: Duration of intervention (12 hours)
measure: Mean fraction of inspired oxygen
timeFrame: Duration of intervention (12 hours)
measure: Mean respiratory rate
timeFrame: Duration of intervention (12 hours)
measure: Mean degrees of phase lag by RIP
timeFrame: Duration of intervention (12 hours)
measure: Number of episodes of feeding intolerance
timeFrame: Duration of intervention (12 hours)
measure: Instances of treatment failure
timeFrame: Duration of intervention (12 hours)
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Brown University
name: Martin Keszler, MD
role: PRINCIPAL_INVESTIGATOR
References: