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Comparison of Two Flow Rates of HHHFNC to Prevent Extubation Failure in Preterm Infants

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ClinicalTrials.gov Identifier: NCT02681315
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
Hesham Abdel-Hady, Mansoura University Children Hospital

Brief Summary:
This is a randomized controlled trial (RCT) to evaluate the influence of two flow rates (6 liter/min versus 3 liter/min) of Heated-Humidified High-Flow-Nasal-Cannula (HHHFNC) on rates of extubation failure in mechanically ventilated preterm infants.

Condition or disease Intervention/treatment Phase
Prematurity, Mechanical Ventilation Device: HHHFNC 6 liter minute Device: HHHFNC 3 liters/min Phase 3

Detailed Description:

HHHFNC has been proposed as an alternative to nasal continuous positive airway pressure (nCPAP) in neonatal intensive care units (NICUs) for preventing extubation failure. In a recent international survey on periextubation practices in extremely preterm infants, nCPAP was the most common type of respiratory support used (84%) followed by nasal intermittent positive pressure ventilation (55%) and HHHFNC (33%). Moreover, HHHFNC appears to have efficacy and safety similar to those of nCPAP when applied immediately post-extubation to prevent extubation failure in preterm infants. and resulted in significantly less nasal trauma in the first 7 days post-extubation than nCPAP. However, the best flow rates of HHHFNC to prevent extubation failure remains to be known.

This RCT aims to compare the efficacy and safety of postextubation respiratory support via HHHFNC at two different flow rates (6 L/min. versus 3 L/min) regarding successful extubation after a period of endotracheal positive pressure ventilation. We hypothesized that postextubation respiratory support via HHHFNC at a flow rate of 6 L/min. will result in a greater proportion of preterm infants being successfully extubated after a period of endotracheal positive pressure ventilation compared with HHHFNC at a flow rate of 3 L/min.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HHHFNC to Prevent Extubation Failure in Preterm Infants: A Randomized Controlled Trial
Study Start Date : March 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: 6 liter/min group
Infants will be extubated to a HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) at flow rate of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
Device: HHHFNC 6 liter minute
Infants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.

Active Comparator: 3 liter/min group
Infants will be extubated to HHHFNC (Fisher and Paykel Healthcare , Auckland, New Zealand) a flow rate of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
Device: HHHFNC 3 liters/min
Infants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.




Primary Outcome Measures :
  1. Extubation failure [ Time Frame: the 7 days after extubation ]

    Extubation failure criteria will be defined as follows:

    1. Apnea (respiratory pause >20 seconds), more than 6 episodes requiring physical stimulation in 6 hours or 1 requiring intermittent positive pressure ventilation.
    2. Respiratory acidosis with pH <7.25 and Peripheral arterial oxygen saturation (PaCO2) >65 mmHg.

    ( >15% sustained increase in FiO2 from extubation. 4. Cardiovascular collapse (heart rate <60 beats per minute or shock. 5. Persistent marked/severe retractions. Extubation failure will be deemed to occur if any single criterion was met in any one of the 7 days after extubation. The decision to reintubate an infant and mechanical ventilation variables and subsequent extubation attempts after reintubation will be managed at the discretion of the clinical team.



Secondary Outcome Measures :
  1. Mortality [ Time Frame: within the 96 hour post-extubation period or at any time after with expected average of 5 weeks ]
    Death within the 96 hour post-extubation period or at any time after randomization.

  2. Total duration of mechanical ventilation [ Time Frame: During NICU admission with expected average of 5 weeks ]
    Total duration of mechanical ventilation during NICU admission

  3. Total duration of oxygen supplementation [ Time Frame: During NICU admission with expected average of 5 weeks ]
    Total duration of oxygen supplementation during NICU admission

  4. Bronchopulmonary dysplasia (BPD) [ Time Frame: at 36 weeks' post-menstrual age. ]
    BPD defined by oxygen requirement at 36 weeks' post-menstrual age.

  5. Severe BPD [ Time Frame: at 36 weeks' post-menstrual age. ]
    Severe BPD defined as oxygen requirement with fraction of inspired oxygen (FiO2) >0.30 or need for positive pressure support at 36 weeks' post-menstrual age.

  6. The combined outcome variables of death before 36 weeks PMA or BPD [ Time Frame: at 36 weeks' post-menstrual age. ]
    The combined outcome variables of death before 36 weeks PMA or BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD.

  7. The combined outcome variables of death before 36 weeks PMA or severe BPD [ Time Frame: at 36 weeks' post-menstrual age ]
    The combined outcome variables of death before 36 weeks' post-menstrual age (PMA) or severe BPD will be used to adjust for occurrence of death after extubation but before the time of assessment of BPD.

  8. Other neonatal morbidities (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity) [ Time Frame: baseline, during the 96 hours post-extubation, and at any time thereafter during NICU stay with an expected average of 5 weeks ]
    The occurrence of neonatal morbidities occurring before, during the 96 hours post-extubation, and at any time thereafter will be documented (intracranial hemorrhage, pneumothorax, patent ductus arteriosus, necrotizing enterocolitis, and retinopathy of prematurity).



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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants born at less than 37 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and are considered ready for extubation by the clinical team. Infants will be enrolled after written informed parental consent is obtained.

Exclusion Criteria:

  • Suspected upper airway obstruction, congenital airway malformations, or major cardiopulmonary malformations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681315


Contacts
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Contact: Hesham E Abdel-Hady +2 01114328500 hehady@yahoo.com

Locations
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Egypt
Neonatal Intensive Care Unit, Mansoura University Children Hospital Recruiting
Mansoura, Dakahlia, Egypt, 35516
Contact: Hesham E Abdel-Hady, MD, PhD    +2 01114328500    hehady@yahoo.com   
Sponsors and Collaborators
Mansoura University Children Hospital

Publications:
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Responsible Party: Hesham Abdel-Hady, Professor of Pediatrics, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT02681315     History of Changes
Other Study ID Numbers: MS/15.10.41
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents