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A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

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ClinicalTrials.gov Identifier: NCT03292562
Recruitment Status : Completed
First Posted : September 25, 2017
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Brittany Lynn Duyka, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine if among infants <30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Respiratory Distress Syndrome Device: Discontinue NCPAP after weaning pressures Device: Discontinue NCPAP without weaning pressures Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study
Actual Study Start Date : September 19, 2017
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 31, 2019


Arm Intervention/treatment
Active Comparator: Discontinue NCPAP after weaning pressures
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Device: Discontinue NCPAP after weaning pressures
After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria (described below) pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).

Active Comparator: Discontinue NCPAP without weaning pressures
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).
Device: Discontinue NCPAP without weaning pressures
After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1L flow, 30% FiO2).




Primary Outcome Measures :
  1. Number of days on NCPAP or mechanical ventilation [ Time Frame: from randomization until 28 days post-randomization ]
    Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.


Secondary Outcome Measures :
  1. Duration of endotracheal ventilation [ Time Frame: from randomization until 28 days post-randomization ]
    Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.

  2. Number of participants who failed to wean off NCPAP [ Time Frame: from randomization until discharge (about 42 to 84 days) ]
  3. Number of participants who developed bronchopulmonary dysplasia [ Time Frame: from randomization until discharge (about 42 to 84 days) ]
  4. Number of participants who developed necrotizing enterocolitis [ Time Frame: from randomization until discharge (about 42 to 84 days) ]
  5. Number of days for participants to be taking all feeds by mouth [ Time Frame: from randomization until discharge (about 42 to 84 days) ]
  6. Length of hospital stay [ Time Frame: from admission to hostpital until discharge (about 42 to 84 days) ]
  7. Number of participants who developed air leak disorders [ Time Frame: from randomization until discharge (about 42 to 84 days) ]
    Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
  • Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm H2O, FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)

Exclusion Criteria:

  • Major congenital anomalies including congenital heart disease
  • Anomalies that prevent discontinuation of NCPAP
  • Undergoing current evaluation for and/or treatment of sepsis

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): NCT03292562


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Brittany Duyka, MD The University of Texas Health Science Center, Houston

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Responsible Party: Brittany Lynn Duyka, Neonatal-Perinatal Medicine Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03292562     History of Changes
Other Study ID Numbers: HSC-MS-17-0334
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019

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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
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases