Extubation Readiness Study in Very Low Birthweight Infants

Study Overview
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Brief Summary
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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).

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

Conditions
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Respiratory Distress Syndrome

Intervention / Treatment
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* Other: spontaneous breathing trial


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 48 Hours
Maximum Age: 14 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |