A Randomized Trial of the Spontaneous Breathing Trial to Extubate Very Low Birthweight Infants

University of Pennsylvania2 sites in 1 country81 target enrollmentAugust 2011

ConditionsRespiratory Distress Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Distress Syndrome
Sponsor: University of Pennsylvania
Enrollment: 81
Locations: 2
Primary Endpoint: time to successful extubation
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

April 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pennsylvania

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

time to successful extubation

Time Frame: 34 weeks postmenstrual age

The time from intubation (if \>48 hours) to successful extubation (if \> 7 days) as evaluated at 34 weeks postmenstrual age (gestational age + chronologic age)