CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure

NCT03670732 | Terminated

• 2 other identifiers: 1010049WIH 17-0037
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Respiratory Distress Syndrome; Apnea of Prematurity

Keywords

Continuous positive airway pressure; Nasal intermittent positive pressure ventilation; Mean airway pressure; Apnea; Bradycardia; Prematurity

Outcome Measures

Primary Outcomes (1)

• Number of Apnea/bradycardia events

  Number of episodes of apnea and/or bradycardia that trigger alarm on the bedside monitor

  Duration of intervention (12 hours)

Secondary Outcomes (8)

• Number of of desaturation events

  Duration of intervention (12 hours)

• Mean oxygen saturation by pulse oximetry and proportion of time below 88%

  Duration of intervention (12 hours)

• Mean transcutaneous PCO2 and proportion of time >55 torr

  Duration of intervention (12 hours)

• Mean fraction of inspired oxygen

  Duration of intervention (12 hours)

• Mean respiratory rate

  Duration of intervention (12 hours)

Study Arms (2)

CPAP first

ACTIVE COMPARATOR

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.

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

NIPPV first

ACTIVE COMPARATOR

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.

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

Interventions

continuous positive airway pressure 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

Also known as: CPAP

CPAP first; NIPPV first

nasal intermittent positive pressure ventilation 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

Also known as: NIPPV

CPAP first; NIPPV first

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Apnea; Bradycardia

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Martin Keszler, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics, Associate Director of NICU, Director of Respiratory Care

Model Details: Crossover non-inferiority trial

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: September 30, 2017
• Primary Completion: March 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)