NCT03091387

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2017

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

March 21, 2017

Last Update Submit

March 21, 2017

Conditions

Neonates

Keywords

neonates, extubation

Outcome Measures

Primary Outcomes (1)

  • Extubation failure

    reintubation within 48 hrs of extubation

    48hrs

Interventions

Spontaneous Breathing TestDIAGNOSTIC_TEST

subjects when ready for extubation will be given a three minute spontaneous breathing test on ET-Cpap mode of the ventilator

Eligibility Criteria

Age1 Day - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates on mechanical ventilation in NICU.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Bancalari E, Sinclair J. Effective care of the newborn infant, 1st ed. New York: Oxford University Press, 1992.

    BACKGROUND

  • Halliday HL. Towards earlier neonatal extubation. Lancet. 2000 Jun 17;355(9221):2091-2. doi: 10.1016/s0140-6736(00)02372-2. No abstract available.

    PMID: 10902619BACKGROUND

  • Stefanescu BM, Murphy WP, Hansell BJ, Fuloria M, Morgan TM, Aschner JL. A randomized, controlled trial comparing two different continuous positive airway pressure systems for the successful extubation of extremely low birth weight infants. Pediatrics. 2003 Nov;112(5):1031-8. doi: 10.1542/peds.112.5.1031.

    PMID: 14595042BACKGROUND

  • Fox WW, Schwartz JG, Shaffer TH. Successful extubation of neonates: clinical and physiological factors. Crit Care Med. 1981 Dec;9(12):823-6. doi: 10.1097/00003246-198112000-00003.

    PMID: 7318452BACKGROUND

  • Khan N, Brown A, Venkataraman ST. Predictors of extubation success and failure in mechanically ventilated infants and children. Crit Care Med. 1996 Sep;24(9):1568-79. doi: 10.1097/00003246-199609000-00023.

    PMID: 8797633BACKGROUND

  • Baumeister BL, el-Khatib M, Smith PG, Blumer JL. Evaluation of predictors of weaning from mechanical ventilation in pediatric patients. Pediatr Pulmonol. 1997 Nov;24(5):344-52. doi: 10.1002/(sici)1099-0496(199711)24:53.0.co;2-i.

    PMID: 9407568BACKGROUND

  • Kamlin CO, Davis PG, Morley CJ. Predicting successful extubation of very low birthweight infants. Arch Dis Child Fetal Neonatal Ed. 2006 May;91(3):F180-3. doi: 10.1136/adc.2005.081083. Epub 2006 Jan 12.

    PMID: 16410255BACKGROUND

Study Officials

  • Ali S. Hussain, MBBS,FCPS

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali S. Hussain, MBBS,FCPS

CONTACT

+922134930051ali.hussain@aku.edu

syed R. Ali, MBBS,FCPS

CONTACT

+922134930051rehan.ali@aku.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior instructor

Study Record Dates

First Submitted

March 21, 2017

First Posted

March 27, 2017

Study Start

April 1, 2017

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share