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Impact of Extended CPAP on Bronchopulmonary Dysplasia

Primary Purpose

Bronchopulmonary Dysplasia, Prematurity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protocolized weaning of respiratory support
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary dysplasia, Prematurity, High flow nasal cannula, Continuous positive airway pressure, NICU

Eligibility Criteria

22 Weeks - 30 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • babies born at <30 weeks' gestation
  • babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age

Exclusion Criteria:

  • babies born at <30 weeks' gestation
  • requiring less than 2L NC at birth or
  • those who are extubated after 32.0 weeks' postmenstrual age
  • congenital anomalies
  • skeletal disorders
  • neuromuscular disorders
  • genetic syndromes

Sites / Locations

  • Christiana Care Health Services, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual care group

Protocol care group

Arm Description

Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol.

Infants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air.

Outcomes

Primary Outcome Measures

Time to reach 2L NC or room air
The primary outcome is time (in days) to reach 2L nasal cannula or room air

Secondary Outcome Measures

Compliance to protocol and balancing measures
compliance to intervention, medical team attitude towards intervention, death, pneumothorax after extubation, septal breakdown, necrotizing enterocolitis (NEC), number of failed wean off respiratory support attempts, duration of noninvasive respiratory support, failure to maintain non-invasive support, duration of Fi02 requirement >21%, need for systemic steroids, time to full enteral feeds, time to initiation of PO feeds, time to >75% PO feeds, length of stay, and growth velocity at discharge.

Full Information

First Posted
September 12, 2022
Last Updated
October 17, 2022
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT05547139
Brief Title
Impact of Extended CPAP on Bronchopulmonary Dysplasia
Official Title
Impact of Extended CPAP Utilization on Bronchopulmonary Dysplasia in Extremely Premature Infants: A Pilot Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2022 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot study is to compare if keeping infants on CPAP (continuous positive airway pressure) support for an extended period of time until they are 32 weeks corrected gestational age or 1250 grams (approximately 2 pounds and 12 ounces) will decrease their degree of lung disease as compared to weaning their respiratory support to HFNC (high flow nasal cannula).
Detailed Description
There are two ways to help premature babies breathe. Both HFNC and CPAP are commonly used in our NICU. CPAP, which helps your baby breathe without a tube in their windpipe (intubation or ventilator), delivers oxygen and air by pressure through either small prongs in the nose or a nose mask, keeping your baby's airways open. HFNC provides heated and humidified oxygen and air by small prongs in the nose that does not use high pressure to the airways. Our goals are to reduce long term complications such as lung disease of prematurity, also called Bronchopulmonary Dysplasia (BPD). BPD causes "lung damage/scarring, need for a ventilator or oxygen, brain/neurological impairment etc. In recent years, HFNC has become a common choice for care. There is no clear agreement in previous research which way may be best to reduce BPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Prematurity
Keywords
Bronchopulmonary dysplasia, Prematurity, High flow nasal cannula, Continuous positive airway pressure, NICU

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Infants will be randomized to the usual care group or the protocol care group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care group
Arm Type
No Intervention
Arm Description
Infants randomized to this group will receive the present standard of care for weaning respiratory support. This means the attending provider will decide when each infant is ready to be changed from CPAP to nasal cannula and the nasal cannula will be weaned according to an existing unit protocol.
Arm Title
Protocol care group
Arm Type
Active Comparator
Arm Description
Infants randomized to this group will remain on CPAP until they are at least 32 weeks corrected gestational age or 1250g. At that point, if they meet a set of criteria, they will be transitioned to either 2L nasal cannula if they require supplemental oxygen or room air.
Intervention Type
Other
Intervention Name(s)
Protocolized weaning of respiratory support
Intervention Description
The protocolized weaning aims to keep babies on CPAP for a longer period of time and will measure how long it takes babies to wean to 2L nasal cannula support or come off all support (room air, RA).
Primary Outcome Measure Information:
Title
Time to reach 2L NC or room air
Description
The primary outcome is time (in days) to reach 2L nasal cannula or room air
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Compliance to protocol and balancing measures
Description
compliance to intervention, medical team attitude towards intervention, death, pneumothorax after extubation, septal breakdown, necrotizing enterocolitis (NEC), number of failed wean off respiratory support attempts, duration of noninvasive respiratory support, failure to maintain non-invasive support, duration of Fi02 requirement >21%, need for systemic steroids, time to full enteral feeds, time to initiation of PO feeds, time to >75% PO feeds, length of stay, and growth velocity at discharge.
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: babies born at <30 weeks' gestation babies who are extubated to non-invasive ventilation by 32 weeks postmenstrual age Exclusion Criteria: babies born at <30 weeks' gestation requiring less than 2L NC at birth or those who are extubated after 32.0 weeks' postmenstrual age congenital anomalies skeletal disorders neuromuscular disorders genetic syndromes
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kelley Z Kovatis, MD
Phone
302-301-2410
Email
kelley.kovatis@christianacare.org
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Mackley, MSN
Phone
302-301-2153
Email
amackley@christianacare.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelley Z Kovatis, MD
Organizational Affiliation
Christiana Care Health Services, Inc
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anastasiya Latushko
Organizational Affiliation
Christiana Care Health Services, Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health Services, Inc.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelley Kovatis, MD
Phone
302-301-2410
Email
kelley.kovatis@christianacare.org
First Name & Middle Initial & Last Name & Degree
Amy Mackley, MSN, CCRC
Phone
302-301-2153
Email
amackley@christianacare.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Extended CPAP on Bronchopulmonary Dysplasia

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