CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

NCT ID: NCT03670732

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-30
• Study Completion Date: 2020-06-30

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.

Conditions

Prematurity; Respiratory Distress Syndrome; Apnea of Prematurity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP 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.

Group Type: ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type: OTHER

Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

nasal intermittent positive pressure ventilation

Intervention Type: OTHER

NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

NIPPV first

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.

Group Type: ACTIVE_COMPARATOR

continuous positive airway pressure

Intervention Type: OTHER

Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

nasal intermittent positive pressure ventilation

Intervention Type: OTHER

NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

Interventions

continuous positive airway pressure

Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

Intervention Type: OTHER

nasal intermittent positive pressure ventilation

NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study

Intervention Type: OTHER

Other Intervention Names

CPAP; NIPPV

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

• Maximum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: lead

Responsible Party

Martin Keszler

Professor of Pediatrics, Associate Director of NICU, Director of Respiratory Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Keszler, MD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Countries

United States

Other Identifiers

WIH 17-0037

Identifier Type: OTHER

Identifier Source: secondary_id

1010049

Identifier Type: -

Identifier Source: org_study_id