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Extubation Readiness Study in Very Low Birthweight Infants

NCT01471431 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2016-06-07

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ann-Johanna Giaccone, MD · University of Pennsylvania

  • Barbara Schmidt, MD, MSc · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
14 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01471431 on ClinicalTrials.gov