TerminatedNot Applicable

CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

Stopped: Unable to obtain needed equipment and COVID-related suspension of clinical research

United States52 participantsStarted 2017-09-30

Plain-language 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.

Who can participate

Age range6 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Apnea/bradycardia events

Timeframe: Duration of intervention (12 hours)

Trial details

NCT IDNCT03670732

SponsorWomen and Infants Hospital of Rhode Island

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-30