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Utility of Spontaneous Breathing Trial (SBT) Using ET-CPAP, in Predicting Extubation Failure in Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03091387
Recruitment Status : Unknown
Verified March 2017 by Ali S. Hussain, Aga Khan University.
Recruitment status was:  Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Information provided by (Responsible Party):
Ali S. Hussain, Aga Khan University

Brief Summary:
Intubation and ventilation are lifesaving interventions in the neonatal intensive care unit (ICU), especially among preterm, low birth weight babies. However, timely extubation is also necessary. The decision to extubate usually depends on clinical judgement, appropriate blood gas prior to extubation and low ventilator parameters. Approximately 40 % of babies' extubated on the above criteria require re-intubation, suggesting that current methods to predict extubation failure are insufficient. . Spontaneous breathing trial (SBT) has been predominantly used in infants and children to access the readiness for extubation. Few studies in premature neonates have also shown good sensitivity and specificity in predicting extubation success. However its significance in our population is yet to be determined. We aim to use this for both our preterm and term babies and if results are significant we plan to include this as our routine pre extubation criteria.

Condition or disease Intervention/treatment
Neonates Diagnostic Test: Spontaneous Breathing Test

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Study Type : Observational
Estimated Enrollment : 110 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Utility of Spontaneous Breathing Trial (SBT) Using ET-CPAP, in Predicting Extubation Failure in Neonates
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : July 2018

Intervention Details:
  • Diagnostic Test: Spontaneous Breathing Test
    subjects when ready for extubation will be given a three minute spontaneous breathing test on ET-Cpap mode of the ventilator

Primary Outcome Measures :
  1. Extubation failure [ Time Frame: 48hrs ]
    reintubation within 48 hrs of extubation

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Neonates on mechanical ventilation in NICU.

Inclusion Criteria:

  • 1. Neonates who are intubated for more than 24 hrs. AND 2. Extubation is planned by the primary team onto Nasal continuous positive airway pressure (NCPAP) for weight < 1.5 kg OR Oxygen via nasal prongs for weight ≥ 1.5 kg

AND having all of the following:

  1. Pre extubation blood gas pH=7.25-7.45 and PCo2=35-45mmHg
  2. Pre extubation fractional inspiration of oxygen (FiO2)=<40%
  3. Is off sedation medication for >4 hrs
  4. I-time= 0.3-0.36 sec
  5. Peep: 5 cm h20
  6. VTe: >3 ml/kg
  7. Breathing rate above the set ventilator rate

    4. Family providing written informed consent

    Exclusion Criteria:

    1. Neonates who will be extubated and kept on other modalities like high flow nasal cannula.
    2. Congenital malformation like lung hypoplasia/diaphrgmatic hernia/congenital cyanotic heart disease.
    3. Neonate with suspicion of neuromuscular disorder.
    4. Neonates with accidental extubation


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03091387

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Contact: Ali S. Hussain, MBBS,FCPS +922134930051 ext 4733
Contact: syed R. Ali, MBBS,FCPS +922134930051 ext 1992

Sponsors and Collaborators
Aga Khan University
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Principal Investigator: Ali S. Hussain, MBBS,FCPS Aga Khan University

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Responsible Party: Ali S. Hussain, Senior instructor, Aga Khan University Identifier: NCT03091387    
Other Study ID Numbers: SBT NICU
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ali S. Hussain, Aga Khan University:
neonates, extubation
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes