Comparing HHHFNC and nCPAP Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants

NCT02887846 | Unknown Phase 4 DMC

• 1 other identifier: 11082016
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

Purpose is to show that HHHFNC method is as effective and safe as nCPAPand even more comfortable than it as non-invasive respiratory support for the prevention of extubation failure in preterm with gestational age of 26-32 weeks. Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.

Conditions

Extubation Failure; Prematurity

Outcome Measures

Primary Outcomes (1)

• extubation failure

  The effectiveness of HHHFNC and nCPAP techniques for the prevention of extubation failure within 7 days following the first extubation in preterms in need of mechanical ventilation within the first 7 postnatal days

  7 day

Study Arms (2)

group 1

ACTIVE COMPARATOR

Heated humidified high-flow nasal cannula therapy device for post extubation

Device: Heated Humidified High-Flow Nasal Cannula

group 2

ACTIVE COMPARATOR

Nasal continuous positive airway pressure for post extubation

Device: Heated Humidified High-Flow Nasal Cannula

Interventions

Heated Humidified High-Flow Nasal Cannula DEVICE

Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 \< 0,40, Pa CO2 \< 65 mmHg, pH\> 7.20, MAP (mean airway pressure) \<7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is\<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 \< 0.30 at 24 hours and above, free oxygen will be introduced.

Also known as: HHHFNC

group 1; group 2

Eligibility Criteria

• Age: 1 Hour - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• Zekai Tahir Burak Women's Health Research and Education Hospital: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: September 2, 2016
• Study Start: August 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: September 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-08