Extubation Readiness Study in Very Low Birthweight Infants

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome
• Interventions: Other: spontaneous breathing trial

• Registration Number: NCT01471431
• Lead Sponsor: University of Pennsylvania

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-11-10
• Study First Submitted QC: 2011-11-10
• Study First Posted: 2011-11-16
• Status Verified: 2015-09
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-06-03
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

• Birthweight >500g and<1500g.
• Postmenstrual age <34 weeks
• Mechanically ventilated >48 hours
• Never successfully extubated

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spontaneous breathing trial	spontaneous breathing trial	The spontaneous breathing trial will determine the extubation readiness of the subject.

Primary Outcome Measures

Name	Time	Method
time to successful extubation	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)

Secondary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia	36 weeks postmenstrual age	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	34 weeks postmenstrual age	The proportion of infants who fail extubation will be compared between the 2 groups.

Trial Locations

Locations (2)

Pennsylvania Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

The Hospital of the University of Pennsylvania; 🇺🇸 Phialdelphia, Pennsylvania, United States