CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure (NICA)

Women and Infants Hospital of Rhode Island

Status: Terminated

Conditions: Prematurity; Respiratory Distress Syndrome; Apnea of Prematurity

Treatments: Other: continuous positive airway pressure; Other: nasal intermittent positive pressure ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT03670732

1010049

WIH 17-0037 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

CPAP first

Active Comparator group

Description:

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.

Treatment:

Other: nasal intermittent positive pressure ventilation

Other: continuous positive airway pressure

NIPPV first

Active Comparator group

Description:

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.

Treatment:

Other: nasal intermittent positive pressure ventilation

Other: continuous positive airway pressure