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Trial record 2 of 127 for:    PAP children

A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

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ClinicalTrials.gov Identifier: NCT03085329
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : March 22, 2017
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Charles Smith, Seattle Children's Hospital

Brief Summary:

This study is designed to test the hypothesis that among infants born at less than 30 weeks, weighing less than 1500 g at delivery, and receiving initial respiratory support non-invasively or on invasive respiratory support and meeting extubation criteria in the first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal intubation and conventional mechanical ventilation (CMV) than will neonates managed from birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- & Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the delivery room or who are stabilized on mechanical ventilation as their initial form of respiratory support and meet our criteria for extubation within 72 h of birth will be eligible for randomization and study.

The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation that occurs in patients after randomization and before 36 weeks post menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports that this age group typically exhibits intubation rates of 50% or more, which is consistent with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU) Neonatal Intensive Care Unit (NICU).


Condition or disease Intervention/treatment Phase
Premature Birth Device: Seattle-PAP Device: Conventional bubble nasal CPAP Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: With written informed consent from the mother or parents, infants born at less than 30 weeks gestation and who are capable of breathing spontaneously within the first 72 hours postnatal, will be supported by bubble nasal continuous positive airway pressure (Bn-CPAP), randomized to the standard device from Fisher & Paykel or to Seattle-PAP.
Masking: None (Open Label)
Masking Description: The nature of this comparative study makes masking device assignment impractical. The objectivity of the outcome assessment will rely upon adherence to formally defined criteria for device support failure.
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Actual Study Start Date : February 10, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : February 9, 2019

Arm Intervention/treatment
Experimental: Seattle-PAP
bubble nasal cpap respiratory support with Seattle-PAP bubbler device, with all other aspects of care per usual care noninvasive respiratory support
Device: Seattle-PAP
Seattle-PAP is a modified bubble CPAP device that has been given 510(k) clearance by the US FDA (K131502, October 11, 2013) and is thus recognized as substantially equivalent to other approved devices on the market. Results of a recently completed study in infants indicate that Bn-CPAP is associated with lower effort to breathe by spontaneously breathing premature infants.

Experimental: Conventional bubble nasal CPAP
qualified and enrolled infants randomized to this arm will receive noninvasive respiratory support by bubble nasal CPAP, using the Fisher & Paykel bubbler, which is the standard of care at Nationwide Children's.
Device: Conventional bubble nasal CPAP
Infants enrolled in the study and randomized to this arm will be given respiratory support by bubble nasal CPAP using the Fisher & Paykel bubbler device, which is the standard of care at Nationwide Children's.




Primary Outcome Measures :
  1. Failure of noninvasive respiratory support [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    The primary endpoint of this study is the cumulative incidence of respiratory failure requiring intubation. The principal criteria for failure of support are the requirement of an FiO2 greater than 0.40 and CPAP of greater than 6 cm H2O to maintain SaO2 of at least 90%. Support failure also can be declared by the responsible clinician based on best clinical judgment, but any declarations not based on the stated criteria will require written explanations.


Secondary Outcome Measures :
  1. pneumothorax [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    by diagnosis of clinical care team

  2. nasal trauma [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    by diagnosis of clinical care team

  3. supplemental oxygen requirement [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    if an infant fails for one hour or more fails to sustain an oxygen saturation (SaO2) of at least 90 percent, with FiO2 of 0.40 or less and 6 cm of water pressure (cmH2O) or less CPAP pressure.

  4. ventilation-associated sepsis [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    by diagnosis of clinical care team

  5. death of infant [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    infant declared dead by responsible clinical care personnel

  6. Central nervous system (CNS) injury [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    intraventricular hemorrhage and/or periventricular leukomalacia

  7. gastrointestinal complications [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    necrotizing enterocolitis and/or spontaneous intestinal perforation

  8. retinopathy of prematurity [ Time Frame: After randomization and before 36 weeks postmenstrual age (PMA) or discharge from the hospital, whichever comes first. ]
    by diagnosis of clinical care team



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure

Exclusion Criteria:

  • Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
  • Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).

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): NCT03085329


Contacts
Contact: Carl H Backes, Jr., MD 614 264-6374 carl.backesjr@nationwidechildrens.org
Contact: Michael Stenger, MD 614 264-3555 michael.stenger@nationwidechildrens.org

Locations
United States, Ohio
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Carl H Backes, Jr., MD    614-264-6374    carl.backesjr@nationwidechildrens.org   
Contact: Michael Stenger, MD    614 264-3555    michael.stenger@nationwidechildrens.org   
Sponsors and Collaborators
Seattle Children's Hospital
Nationwide Children's Hospital
Investigators
Principal Investigator: Carl H Backes, Jr., MD Nationwide Children's Hospital

Publications of Results:
Other Publications:
Responsible Party: Charles Smith, Professor of Pediatrics, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT03085329     History of Changes
Other Study ID Numbers: Seattle-PAP 002
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The data will be available for download via Globus sharing services from the Seattle-PAP shared endpoint.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Charles Smith, Seattle Children's Hospital:
bubble nasal continuous positive airway pressure
respiratory support

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications