Extubation Readiness Study in Very Low Birthweight Infants

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01471431
• Other study ID #: 813859
• Status: Terminated
• Phase: N/A
• First received: November 10, 2011
• Last updated: June 3, 2016
• Start date: August 2011
• Est. completion date: April 2016

Study information

• Verified date: September 2015
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 81
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 14 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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.

Locations

Country	Name	City	State
United States	The Hospital of the University of Pennsylvania	Phialdelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	extubation failure rate	The proportion of infants who fail extubation will be compared between the 2 groups.	34 weeks postmenstrual age	No