Seattle-PAP Bubble Nasal CPAP and Work of Breathing

Phase 1

Completed

• Conditions: Newborn Primary Sleep Apnea; Bronchopulmonary Dysplasia; Respiratory Distress Syndrome In Premature Infants
• Interventions: Device: Seattle-PAP

• Registration Number: NCT02210026
• Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description

The primary outcome variable is work of breathing (WOB) over a two hour period, 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. The following endpoints would also be assessed: Oxygen saturations and Fraction of Inspired Oxygen (FiO2) needed to keep saturations in acceptable ranges, Heart Rates (HR), transcutaneous carbon dioxide (TcPCO2), and respiratory rates throughout the 6 hour study period.

Objective determination of when an infant requires more or less respiratory support is difficult, but measurements of pressure-rate products as estimates of work of breathing, using esophageal catheters, can estimate an infant's respiratory effort. However, objective, simple-to-use, low cost, and non-invasive methods and tools to determine an infant's respiratory effort do not exist currently.

This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-04
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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

Exclusion Criteria

• major congenital anomalies or suspected chromosomal anomalies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Work of Breathing	Six hours	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.

Secondary Outcome Measures

Name	Time	Method
Video Recordings of Chest and Abdomen Movements during Breathing	Six hours	This study also is designed to test the hypothesis that infants' chest and abdominal movements can be assessed quantitatively from video images in ways that can be correlated with intrathoracic pressures, as measured with esophageal catheters.

Trial Locations

Locations (1)

Texas Children's Hospital; 🇺🇸 Houston, Texas, United States