Seattle-PAP Bubble Nasal CPAP and Work of Breathing

Bronchopulmonary Dysplasia Clinical Trial

— Seattle-PAP  

Official title:

A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210026
• Other study ID #: Seattle-PAP 001
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2014
• Last updated: April 12, 2016
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Newborn Primary Sleep Apnea
• Premature Birth
• Respiratory Distress Syndrome In Premature Infants
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sleep Apnea, Central

Intervention

Device:
• Seattle-PAP
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.

Locations

Country	Name	City	State
United States	Texas Children's Hospital	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Baylor College of Medicine, Texas Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FiO2	Fraction of Inspired Oxygen (FiO2) needed to keep oxygen saturations in acceptable ranges will be assessed throughout the 6 hour study period.	Six hours
Other	Heart Rates	Heart rates will be assessed during the study period.	Six hours
Other	Transcutaneous Carbon Dioxide Levels	Transcutaneous carbon dioxide (TcPCO2) levels will be assessed.	Six hours
Other	Respiratory Rates	Respiratory rates will be assessed.	Six hours
Primary	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	Video Recordings of Chest and Abdomen Movements during Breathing	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.	Six hours