Extubation Readiness Study in Very Low Birthweight Infants

NCT01471431 | Terminated DMC

• 1 other identifier: 813859
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

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).

Conditions

Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• bronchopulmonary dysplasia

  36 weeks postmenstrual age

• extubation failure rate

  34 weeks postmenstrual age

Study Arms (2)

Spontaneous breathing trial

EXPERIMENTAL

The spontaneous breathing trial will determine the extubation readiness of the subject.

Other: spontaneous breathing trial

Usual care

NO INTERVENTION

Subjects will be extubated using usual care, without the use of the spontaneous breathing trial.

Interventions

spontaneous breathing trial OTHER

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.

Spontaneous breathing trial

Eligibility Criteria

• Age: 48 Hours - 14 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (2)

The Hospital of the University of Pennsylvania

Phialdelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Ann-Johanna Giaccone, MD

  University of Pennsylvania

  STUDY DIRECTOR

• Barbara Schmidt, MD, MSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 16, 2011
• Study Start: August 1, 2011
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2015-09

Locations

US (2)