A TRIAL OF SPONTANEOUS BREATHING TO DETERMINE THE READINESS FOR EXTUBATION IN VENTILATED NEW BORNS-PILOT STUDY

RCT OF SBT (SPONTANEOUS BREATHING TRIAL) IN VENTILATED NEWBORNS TO EVALUATE REINTUBATION AND VENTILATION DURATION-PILOT STUDY.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2008/091/000303

Enrollment

Registered

2009-03-03

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Babies fulfilling the SBT entrance criteria, will be given a 3 minute trial once a day until either extubation criteria are met or unplanned extubation occurs or when the attending clin

or = 45bpm, 2. Volume guarantee &lt

or = 4.5 ml/kg or 3. Peak inspiratory pressures &lt

or = 25 cm H2O, 4. Inspired fractional oxygen &lt

or = 40 %. Criteria for failed SBT: 1. The infant had bradycardia &lt

100/min for &gt

15 seconds. 2. The SpO2 falls below 85% despite a 15% increase in fractional inspired oxygen during the period of ET CPAP. Criteria for reintubation: (a) More than six episodes of apnoea requiring st

65 mm Hg (&gt

8.5kPa) and pH &lt

7.25. (c) FiO2 &gt

0.60 to maintain SpO2 in the target range of 90-94%. (d) Increased work of breathing observed and discussed with the treating clinician who will decide if reintubation is warranted. Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: All ventilated newborn babies in nursery will be included in the study subject to obtaining a written consent from parents.

Exclusion criteria

Exclusion criteria: Babies deemed unlikely survivors (Infants with lethal or chromosomal malformations ) and those who do not survive upto extubation will be excluded.

Design outcomes

Primary

Measure	Time frame
To study Spontaneous Breathing Trials in a Randomized Controlled Trial to see: Need for reintubation ( Extubation failure).Timepoint: 72 hrs.	—

Secondary

Measure	Time frame
1). Duration of Ventilation 2). Duration of hospitalisation.Timepoint: 10 days.	—

Countries

India

Contacts

Public ContactJacob M Puliyel

puliyel@gmail.com9868035091

Outcome results