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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prematurity; Extubation Failure
• Intervention / Treatment: Device: Heated Humidified High-Flow Nasal Cannula

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: HHHFNC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): July 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (Estimate): September 2, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 11082016