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Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP

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ClinicalTrials.gov Identifier: NCT01939067
Recruitment Status : Withdrawn (Application for regulatory approval withdrawn)
First Posted : September 11, 2013
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief Summary:
This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.

Condition or disease Intervention/treatment Phase
Respiratory Distress Lung Injury Device: Heated Humidified High Flow Nasal Cannula Device: Nasal Continuous Positive Airway Pressure Phase 1

Detailed Description:

Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.

This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
Study Start Date : March 2014
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
HHHFNC

Treatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC).

Escalation of the ventilatory support per protocol and the attending physician.

Device: Heated Humidified High Flow Nasal Cannula
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.

NCPAP

Treatment of respiratory distress by nasal continuous positive airway pressure (NCPAP).

Escalation of the ventilatory support per protocol and the attending physician.

Device: Nasal Continuous Positive Airway Pressure
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.




Primary Outcome Measures :
  1. Pulmonary mechanics and chest wall asynchrony measures. [ Time Frame: 2 years ]
    Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.


Secondary Outcome Measures :
  1. Duration of respiratory support or oxygen use up to the time of discharge from the NICU. [ Time Frame: 2 years ]
    The total number of days while infants are on any type of respiratory support or oxygen use prior to discharge in preterm infants treated with HHHFNC compared to NCPAP during their hospital stay.

  2. The incidence of potential adverse outcomes associated with HHHFNC or NCPAP. [ Time Frame: 2 years ]
    The number and percentage of infants in each group with adverse effects such as facial and upper airways injury associated with the use of HHHFNC or NCPAP.

  3. Time needed to establish full enteral feeds [ Time Frame: 2 years ]
    The total number of days needed to establish full enteral feeds in preterm infants treated with HHHFNC as compared to preterm infants treated with NCPAP.



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Birth weight greater than or equal to 1000 grams.
  2. Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
  3. Candidate for non-invasive respiratory support as a result of:

    1. An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
    2. An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
  4. Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.

Exclusion Criteria:

  1. Birth weight less than 1000 grams.
  2. Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
  3. Active air leak syndrome.
  4. Subjects will not be eligible if they are not considered viable.
  5. Infants with abnormalities of the upper and lower airways
  6. Infants with significant abdominal or respiratory 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): NCT01939067


Locations
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United States, Pennsylvania
Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Soraya Abbasi, MD University of Pennsylvania

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01939067     History of Changes
Other Study ID Numbers: 12-009882
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Children's Hospital of Philadelphia:
respiratory distress
Heated Humidified High Flow Nasal Cannula (HHHFNC)
HHHFNC
noninvasive nasal continuous positive airway pressure (NCPAP)
NCPAP

Additional relevant MeSH terms:
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Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries