Seattle-PAP Bubble Nasal CPAP and Work of Breathing

NCT02210026 | Completed Phase 1 DMC

• 1 other identifier: Seattle-PAP 001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to test the hypothesis that Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) supports respiratory physiology in very low birth weight (VLBW) infants more effectively than standard bubble nasal continuous positive airway pressure.

Conditions

Respiratory Distress Syndrome In Premature Infants; Bronchopulmonary Dysplasia; Newborn Primary Sleep Apnea

Keywords

bubble nasal continuous positive airway pressure (Bn-CPAP); work of breathing; pressure-rate products

Outcome Measures

Primary Outcomes (1)

• Work of Breathing

  The primary outcome variable is work of breathing (WOB) over three two hour periods, estimated from pressure-rate products, which are assessed with 6 Fr (2 mm) catheters placed in the distal esophagus for monitoring esophageal pressures (Pes), thereby estimating changes in pleural pressures during breath cycles.

  Six hours

Secondary Outcomes (1)

• Video Recordings of Chest and Abdomen Movements during Breathing

  Six hours

Other Outcomes (4)

• FiO2

  Six hours

• Heart Rates

  Six hours

• Transcutaneous Carbon Dioxide Levels

  Six hours

Study Arms (1)

Experimental

EXPERIMENTAL

Infants will be assessed on standard bubble nasal CPAP, then on Seattle-PAP bubble nasal CPAP, then again on standard bubble nasal CPAP.

Device: Seattle-PAP

Interventions

Seattle-PAP DEVICE

We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.

Also known as: Sea-PAP

Experimental

Eligibility Criteria

• Age: 6 Hours - 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infant born less than 32 weeks gestation
• admitted to texas pavilion for women
• between 6 and 72 hours post delivery
• stable on standard bubble nasal CPAP
• informed consent

You may not qualify if:

• major congenital anomalies or suspected chromosomal anomalies

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome In Premature Infants; Bronchopulmonary Dysplasia; Sleep Apnea, Central

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Charles V Smith, PhD

  Seattle Children's Hospital

  STUDY DIRECTOR

• Stephen E Welty, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 6, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: April 14, 2016

Record last verified: 2016-04

Locations

US (1)