Clinical trial NCT02210026: Seattle-PAP Bubble Nasal CPAP and Work of Breathing
Official title: A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Baylor College of Medicine
First posted: 2014-08-06
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Work of Breathing
timeFrame: Six hours
Secondary outcomes:
measure: Video Recordings of Chest and Abdomen Movements during Breathing
timeFrame: Six hours
Other outcomes:
measure: FiO2
timeFrame: Six hours
measure: Heart Rates
timeFrame: Six hours
measure: Transcutaneous Carbon Dioxide Levels
timeFrame: Six hours
measure: Respiratory Rates
timeFrame: Six hours
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Seattle Children's Hospital
name: Charles V Smith, PhD
role: STUDY_DIRECTOR
affiliation: Baylor College of Medicine
name: Stephen E Welty, MD
role: PRINCIPAL_INVESTIGATOR
References: