Extubation Readiness Study in Very Low Birthweight Infants
Primary Purpose
Respiratory Distress Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
spontaneous breathing trial
Sponsored by
About this trial
This is an interventional supportive care trial for Respiratory Distress Syndrome
Eligibility Criteria
Inclusion Criteria:
- Birthweight >500g and<1500g.
- Postmenstrual age <34 weeks
- Mechanically ventilated >48 hours
- Never successfully extubated
Exclusion Criteria:
- Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
- Known or suspected airway anomalies
- Severe congenital malformations
- Need to remain intubated for other reasons (i.e. having surgery)
- Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Sites / Locations
- The Hospital of the University of Pennsylvania
- Pennsylvania Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Spontaneous breathing trial
Usual care
Arm Description
The spontaneous breathing trial will determine the extubation readiness of the subject.
Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.
Outcomes
Primary Outcome Measures
time to successful extubation
The time from intubation (if >48 hours) to successful extubation (if > 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)
Secondary Outcome Measures
bronchopulmonary dysplasia
The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition.
extubation failure rate
The proportion of infants who fail extubation will be compared between the 2 groups.
Full Information
NCT ID
NCT01471431
First Posted
November 10, 2011
Last Updated
June 3, 2016
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01471431
Brief Title
Extubation Readiness Study in Very Low Birthweight Infants
Official Title
A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Futility analysis by DSMC recommended termination.
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to determine whether use of the spontaneous breathing trial allows for earlier successful extubation of very low birth weight (VLBW) infants who are intubated for >48 hours and have not yet been successfully extubated (extubated >7 days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous breathing trial
Arm Type
Experimental
Arm Description
The spontaneous breathing trial will determine the extubation readiness of the subject.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.
Intervention Type
Other
Intervention Name(s)
spontaneous breathing trial
Intervention Description
The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40).
During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia <100 for >15 seconds or oxygen saturation by pulse oximetry <85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met.
Primary Outcome Measure Information:
Title
time to successful extubation
Description
The time from intubation (if >48 hours) to successful extubation (if > 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)
Time Frame
34 weeks postmenstrual age
Secondary Outcome Measure Information:
Title
bronchopulmonary dysplasia
Description
The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition.
Time Frame
36 weeks postmenstrual age
Title
extubation failure rate
Description
The proportion of infants who fail extubation will be compared between the 2 groups.
Time Frame
34 weeks postmenstrual age
10. Eligibility
Sex
All
Minimum Age & Unit of Time
48 Hours
Maximum Age & Unit of Time
14 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Birthweight >500g and<1500g.
Postmenstrual age <34 weeks
Mechanically ventilated >48 hours
Never successfully extubated
Exclusion Criteria:
Congenital heart disease (other than patent ductus arteriosus (PDA), patent foramen ovale (PFO), and restrictive ventricular septal defect (VSD)
Known or suspected airway anomalies
Severe congenital malformations
Need to remain intubated for other reasons (i.e. having surgery)
Has met SBT criteria on previous calendar day (after 48 hrs of ventilation, PIP≤18, PEEP≤6, FiO2≤40%, Rate≤30, PS≤8)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann-Johanna Giaccone, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Barbara Schmidt, MD, MSc
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital of the University of Pennsylvania
City
Phialdelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extubation Readiness Study in Very Low Birthweight Infants
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