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

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ClinicalTrials.gov Identifier: NCT02887846
Recruitment Status : Unknown
Verified August 2016 by Zekai Tahir Burak Women's Health Research and Education Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 2, 2016
Last Update Posted : September 13, 2016
Sponsor:
Information provided by (Responsible Party):
Zekai Tahir Burak Women's Health Research and Education Hospital

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.


Condition or disease Intervention/treatment Phase
Extubation Failure Prematurity Device: Heated Humidified High-Flow Nasal Cannula Phase 4

Detailed Description:

Purpose is to show that HHHFNC method is as effective and safe as nCPAP and 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.

Method

Primary Outcome Measures:

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

Secondary Outcome Measures:

  • the total duration of invasive and non-invasive respiratory support and the duration of free oxygen demand of patients
  • Premature morbidities such as PDA, NEC, ROP, IVH, BPDand sepsis
  • The degree of nasal trauma score and the degree of nasal mucosal injury
  • FiO2 levels first before extubation and 6 hours after extubation
  • The causes of reintubation such as apnea, acidosis, and increased need of FiO2
  • The reintubation predisposing factors such as pneumothorax, atelectasis, PDA after extubation
  • The weight change in the first 7-day period after extubation
  • The two groups in terms of neurodevelopmental changes

Study design 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.

Reintubation criteria is set as;

  • FiO2 of ≥ 0.50 in order to keep oxygen saturation measured by pulse oximetry above 90 % and higher,
  • Apnea requiring more than 6 alerts in a 24 -hour period in 6 consecutive hours or more than 1 apnea requiring positive pressure ventilation,
  • Persistent acidosis; presence of pH < 7.20 and PCO2 > 65 mmHg in two different blood gases drawn with an interval of at least 30 minutes or treatment-resistant metabolic acidosis,
  • Severe respiratory distress,
  • Pulmonary haemorrhage and cardiopulmonary arrest.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing Heated Humidified High-flow Nasal Cannula Therapy and Nasal Continuous Positive Airway Pressure (nCPAP) Ventilation Methods for the Prevention of Extubation Failure in Preterm Infants Less Than 32 Weeks' Gestational Age: Randomized Clinical Trial
Study Start Date : August 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : September 2017

Arm Intervention/treatment
Active Comparator: group 1
Heated humidified high-flow nasal cannula therapy device for post extubation
Device: Heated Humidified High-Flow Nasal Cannula
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.
Other Name: HHHFNC

Active Comparator: group 2
Nasal continuous positive airway pressure for post extubation
Device: Heated Humidified High-Flow Nasal Cannula
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.
Other Name: HHHFNC




Primary Outcome Measures :
  1. extubation failure [ Time Frame: 7 day ]
    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



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Ages Eligible for Study:   up to 7 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Preterm infants with gestational age between 26 weeks 0 days and 31 weeks 6 days will be included.

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Exclusion Criteria: 1- Presence of major congenital anomaly, 2- Presence of neuromuscular disease, 3- Need of surgery within 7 days following the extubation 4- Consent not provided or refused

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Responsible Party: Zekai Tahir Burak Women's Health Research and Education Hospital
ClinicalTrials.gov Identifier: NCT02887846    
Other Study ID Numbers: 11082016
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications