NCT02392806

Brief Summary

Multiple different devices are available to provide Bubble CPAP to preterm and newborn infants. The most significant difference between these devices is the size of the bubble produced by the exhalation limb. This study will determine if one Bubble CPAP device (BabiPlus vs B\&B) is more effective in improving oxygenation and decreasing extubation failure in the extremely low birthweight population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 19, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 26, 2017

Completed
Last Updated

March 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1.6 years

First QC Date

February 27, 2015

Results QC Date

September 14, 2017

Last Update Submit

February 9, 2018

Conditions

Respiratory Distress Syndrome

Keywords

Continuous positive airway pressureCPAPBubble CPAPExtubation failurePreterm infant

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Extubation Failure

    Bubble CPAP failure (re-intubation or use of non-invasive positive pressure ventilation) within 72 hours following extubation

    Within 72 hours of extubation

Secondary Outcomes (1)

  • Oxygenation - Oxygen Saturation Via Pulse Oximetry Recorded Hourly

    96 hours

Study Arms (2)

BabiPlus, Respiralogics

ACTIVE COMPARATOR

Infants randomized to the BabiPlus device will be extubated to BabiPlus Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the B\&B Bubbler device for 24 hours

Device: Bubble CPAP- BabiPlus, Respiralogics

B&B Bubbler, B&B medical Technologies

ACTIVE COMPARATOR

Infants randomized to the B\&B Bubbler device will be extubated to B\&B Bubbler Bubble CPAP device and after 72 hours, if the infant has remained extubated, will be crossed-over to the BabiPlus device for 24 hours

Device: Bubble CPAP- B&B Bubbler, B&B Medical devices

Interventions

Bubble CPAP- BabiPlus, RespiralogicsDEVICE

Infant will be randomized to BabiPlus Bubbler at time of extubation

Also known as: Bubble Continuous Positive Airway Pressure (BCPAP)
BabiPlus, Respiralogics
Bubble CPAP- B&B Bubbler, B&B Medical devicesDEVICE

Infant will be randomized to B\&B Bubbler at time of extubation

B&B Bubbler, B&B medical Technologies

Eligibility Criteria

Age1 Day - 100 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant delivered at \>=500 grams and \<=1250 grams birth weight.
  • Infant requires intubation for mechanical ventilation within the first 48 hours following delivery.
  • Infant has received exogenous surfactant during mechanical ventilation.

You may not qualify if:

  • Decision by attending physician to redirect to comfort care
  • Congenital condition that precludes the use of CPAP (choanal atresia, diaphragmatic hernia, etc.)
  • Birth weight \>1250 grams or \<500 grams.
  • Non-English speaking parents. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

MeSH Terms

Conditions

Respiratory Distress SyndromePremature Birth

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Noah Hillman
Organization
Saint Louis University
noah.hillman@health.slu.edu
3145779292

Study Officials

  • Noah H Hillman, M.D.

    Associate Director, Pediatrics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Pediatrics

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 19, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 9, 2018

Results First Posted

December 26, 2017

Record last verified: 2018-02

Locations

US(1)