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Clinical Trials/CTRI/2024/09/073484
CTRI/2024/09/073484
Not yet recruiting
Not Applicable

Efficacy of Nasal high frequency oscillatory ventilation (nHFOV) VERSUS Synchronised non-invasive positive pressure ventilation (SNIPPV) VERSUS Nonsynchronised non-invasive positive pressure ventilation (NS-NIPPV) as a post extubation respiratory support in preterm neonates (≥ 28 WEEKS OF GESTATION) admitted in a tertiary care centre – A 3 ARM RANDOMIZED CONTROL TRIAL

Neonatology Departmental Fund1 site in 1 country129 target enrollmentStarted: September 15, 2024Last updated:
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Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Neonatology Departmental Fund
Enrollment
129
Locations
1
Primary Endpoint
Extubation failure within 72 hours
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

We hypothesize that nHFOV, SNIPPV & NS-NIPPV are equally efficacious as a mode of respiratory support after extubation & reduce the need for endotracheal re-intubation. Comparison of nHFOV with NIPPV is still in its infancy and more studies are required to come to a consensus statement. In this study we have planned to compare nHFOV versus SNIPPV versus NS-NIPPV as a post extubation respiratory mode in preterm neonates more than equal to 28 weeks of gestational age admitted in a tertiary care centre from eastern India which to the best of our knowledge has not been done so far.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
7.00 Month(s) to 11.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • •Infants born ≥28 weeks of gestation
  • •Inborn babies upto postnatal age 15 days
  • •Mechanically ventilated for at least 12 hrs.

Exclusion Criteria

  • •Infant born at less than 28 weeks of gestational age
  • •Outborn babies
  • •Major congenital anomalies or suspected chromosomal anomalies
  • •Upper airway malformations
  • •Severe perinatal asphyxia.

Outcomes

Primary Outcomes

Extubation failure within 72 hours

Time Frame: Extubation failure within 72 hours

Secondary Outcomes

  • 1. Bronchopulmonary dysplasia (BPD)(2. Mortality (all causes within NICU stay/ upto 28)

Investigators

Sponsor
Neonatology Departmental Fund
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sk samim

IPGMER & SSKM HOSPITAL

Study Sites (1)

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