Extubation Readiness Study in Very Low Birthweight Infants

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

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).

Study Overview

• Status: Terminated
• Conditions: Respiratory Distress Syndrome
• Intervention / Treatment: Other: spontaneous breathing trial

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Phialdelphia, Pennsylvania, United States, 19104
      • The Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pennsylvania Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 days to 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spontaneous breathing trial; The spontaneous breathing trial will determine the extubation readiness of the subject.	Other: spontaneous breathing trial; 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.
No Intervention: Usual care; Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	34 weeks postmenstrual age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bronchopulmonary dysplasia	The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition.	36 weeks postmenstrual age
extubation failure rate	The proportion of infants who fail extubation will be compared between the 2 groups.	34 weeks postmenstrual age

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Barbara Schmidt, MD, MSc, University of Pennsylvania; Study Director: Ann-Johanna Giaccone, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 10, 2011
• First Submitted That Met QC Criteria: November 10, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 3, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Body Weight; Infant, Premature, Diseases; Birth Weight; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: 813859