ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 25 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Low Birth Weight"

A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03298035
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Catherine Claire Beaullieu, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to determine whether nasal intermittent positive pressure ventilation (NIPPV) reduces the need for endotracheal intubation in very low birth weight infants with persistent apnea who fail nasal continuous positive airway pressure (NCPAP).

Condition or disease Intervention/treatment Phase
Apnea of Prematurity Device: NCPAP as mode for apnea prevention Device: NIPPV as rescue mode for apnea prevention Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparison of Non-invasive Ventilation Methods Used to Prevent Endotracheal Intubation Due to Apnea in Very Low Birth Weight Infants
Actual Study Start Date : November 11, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: NCPAP as mode for apnea prevention
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
Device: NCPAP as mode for apnea prevention
With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.

Experimental: NIPPV as rescue mode for apnea prevention
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
Device: NIPPV as rescue mode for apnea prevention
With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.




Primary Outcome Measures :
  1. Number of intubations [ Time Frame: 28 days after randomization ]
  2. Duration of intubation [ Time Frame: 28 days after randomization ]

Secondary Outcome Measures :
  1. Number of apneic events [ Time Frame: 28 days after randomization ]
  2. Number of participants with bronchopulmonary dysplasia (BPD) [ Time Frame: 36 weeks corrected gestational age ]
  3. Number of participants with necrotizing enterocolitis (NEC) [ Time Frame: 36 weeks corrected gestational age ]
  4. Number of participants with air leak disorders [ Time Frame: 36 weeks corrected gestational age ]
    Air leak disorders include pneumothorax and/or pneumomediastinum.

  5. Weight gain [ Time Frame: 36 weeks corrected gestational age ]
  6. Length of hospital stay [ Time Frame: about 10 to 18 weeks ]
  7. Death [ Time Frame: until discharge (about 10 to 18 weeks) or death ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Infants born at < 30 weeks gestational age who develop clinically significant apnea while on NCPAP > 6cm H2O or whose team is considering intubation due to apnea. Consider clinically significant apnea as 1 or more events treated with bag-mask ventilation or 3 episodes of apnea requiring stimulation within 1 hour.
  • Infants on maximum caffeine therapy (10mg/kg/day)

Exclusion Criteria:

- Major congenital anomalies including congenital heart disease


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): NCT03298035


Contacts
Contact: Claire Beaullieu, MD (713)500-6044 Catherine.C.Beaullieu@uth.tmc.edu

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 70030
Contact: Claire Beaullieu, MD    713-500-6044    Catherine.C.Beaullieu@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Claire Beaullieu, MD The University of Texas Health Science Center, Houston

Responsible Party: Catherine Claire Beaullieu, Neonatal-Perinatal Medicine Fellow, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03298035     History of Changes
Other Study ID Numbers: HSC-MS-17-0458
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: July 3, 2018
Last Verified: November 2017

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:
Apnea
Birth Weight
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Body Weight