Extubation Readiness Study in Very Low Birthweight Infants

University of Pennsylvania81 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Respiratory Distress Syndrome

Interventions

spontaneous breathing trialOTHER

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.

Eligibility

Sex: ALLMin age: 48 HoursMax age: 14 Weeks

Medical Language ↔ Plain English

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)

Locations (2)

The Hospital of the University of Pennsylvania

Phialdelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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)

Time frame: 34 weeks postmenstrual age

Secondary Outcomes

bronchopulmonary dysplasia

The diagnosis of bronchopulmonary dysplasia will be made at 36 weeks postmenstrual age, using the traditional definition and the NIH Consensus definition.

Time frame: 36 weeks postmenstrual age

extubation failure rate

The proportion of infants who fail extubation will be compared between the 2 groups.

Time frame: 34 weeks postmenstrual age

Data from ClinicalTrials.gov

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