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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02210026
Other study ID # Seattle-PAP 001
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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