A Comparison of Non-invasive Ventilation Methods Used to... | NCT03298035

NCT03298035

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NCPAP as mode for apnea prevention	Active Comparator	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
NIPPV as rescue mode for apnea prevention	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NCPAP as mode for apnea prevention	Device	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.

Outcomes Module

Measure	Description	Time Frame
Number of Participants Who Were Intubated		28 days after randomization
Duration of Intubation		28 days after randomization

Secondary Outcomes

Measure	Description	Time Frame
Number of Apneic Events		28 days after randomization
Number of Participants With Bronchopulmonary Dysplasia (BPD)		36 weeks corrected gestational age
Number of Participants With Necrotizing Enterocolitis (NEC)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Claire Beaullieu, MD	The University of Texas Health Science Center, Houston	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
The University of Texas Health Science Center at Houston		Houston	Texas	70030	United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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. 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.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 12, 2017

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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. 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.
BG001	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. 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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00010 BG0019 BG00219

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Gestational age

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00025.8± 0.8 BG00125.8± 2.2 BG00225.8± 1.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007 BG0012 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

African American

Title	Measurements
	BG0003 BG0014 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00010 BG0019 BG002

Birth Weight

Mean

Standard Deviation

grams

Title

Denominators

Categories

Title	Measurements
	BG000773± 160.5 BG001858± 293.4 BG002

Weight at Enrollment

Mean

Standard Deviation

grams

Title

Denominators

Categories

Title	Measurements
	BG000920± 286.6 BG001921± 204.4 BG002

Corrected Gestational Age

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00028.4± 2.5 BG00128.4± 1.1 BG002

Number of Participants with Antenatal Glucocorticoid Exposure

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0005 BG0013 BG002

Number of Participants Who Received Surfactant

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0007 BG0016 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Were Intubated

Posted

Count of Participants

Participants

28 days after randomization

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Units	Counts
Participants	OG00010 OG0019

Title

Denominators

Categories

Title	Measurements
	OG0006 OG0018

Primary

Duration of Intubation

Posted

Mean

Standard Deviation

days

28 days after randomization

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Number of Apneic Events

One participant in the NIPPV group died; therefore, this data was not collected for that participant.

Posted

Mean

Standard Deviation

Number of apneic events

28 days after randomization

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Number of Participants With Bronchopulmonary Dysplasia (BPD)

One participant in the NIPPV group died; therefore, this data was not collected for that participant.

Posted

Count of Participants

Participants

36 weeks corrected gestational age

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Number of Participants With Necrotizing Enterocolitis (NEC)

One participant in the NIPPV group died; therefore, this data was not collected for that participant.

Posted

Count of Participants

Participants

36 weeks corrected gestational age

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Number of Participants With Air Leak Disorders

Air leak disorders include pneumothorax and/or pneumomediastinum.

One participant in the NIPPV group died; therefore, this data was not collected for that participant.

Posted

Count of Participants

Participants

36 weeks corrected gestational age

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Weight Gain

Data were not collected for this outcome measure.

Posted

36 weeks corrected gestational age

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Length of Hospital Stay

One participant in the NIPPV group died; therefore, this data was not collected for that participant.

Posted

Mean

Standard Deviation

days

about 10 to 18 weeks

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Secondary

Number of Participants Who Died

Posted

Count of Participants

Participants

until discharge (about 10 to 18 weeks) or death

ID	Title	Description
OG000	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. 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.
OG001	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. 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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. 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.	1	10	0	10	0	10
EG001	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. 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.	0	9	0	9	0	9

This was a pragmatic trial with inherent bias, as blinding was not possible. There was a small sample size (intent was to enroll 50, but only a few of all screened qualified for escalation of care).

Certain Agreements

ID	Term
D001049	Apnea

Units	Counts
Participants	OG0000 OG0010

Units	Counts
Participants	OG0009 OG0019

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms