Work of Breathing in Premature Infants at Discharge | NCT03682575

Studies
Work of Breathing in Premature Infants at Discharge

NCT03682575

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Apr 18, 2023Actual

Enrollment

78Actual

Phase

Not provided

Conditions

Bronchopulmonary Dysplasia
Very Low Birth Weight Infant
Prematurity

Interventions

Enrollment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2020Actual

Primary Completion Date

Nov 17, 2022Actual

Completion Date

Feb 28, 2023Actual

First Submitted Date

Sep 21, 2018

First Submission Date that Met QC Criteria

Sep 21, 2018

First Posted Date

Sep 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to compare how premature infants who required oxygen for at least 28 days during their time in the NICU (Neonatal Intensive Care Unit) breathe at discharge compared to premature infants who did not require oxygen for at least 28 days during their time in the NICU.

Detailed Description

Work of breathing tests will be performed on premature infants who required oxygen for at least 28 days during their time in NICU. These same work of breathing tests will be performed in another group of premature infants who did not require oxygen for at least 28 days during their time in the NICU. The two groups will be compared.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)		Preterm infants who were on oxygen at 28 days of life.	Other: Enrollment
Infants WITHOUT diagnosis of bronchopulmonary dysplasia (BPD		Preterm infants who were not on oxygen at 28 days of life.	Other: Enrollment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enrollment	Other	All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.	Infants WITH diagnosis of bronchopulmonary dysplasia (BPD)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Work of breathing indices	Respiratory Inductance Plethysmography (RIP) measurements will be taken and Phase Angle will be measured.	25 minutes

Secondary Outcomes

Measure	Description	Time Frame
Intermittent Hypoxia	Oxygen saturation will be measured using a high resolution pulse oximeter.	25 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infants born at greater than 26 weeks gestation, weighing less than 1500 grams at birth.
Infants with diagnosis of BPD and without diagnosis of BPD

Exclusion Criteria:

Infants with skeletal, neuromuscular, or abdominal surgical disorders that affect the accuracy of work of breathing measurements will be excluded.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Month

Maximum Age

7 Months

Standard Ages

Child

Study Population

Preterm infants born greater than 26 weeks gestation, weighing less than 1500 grams at birth. Work of breathing indices will be compared between the group of babies who were diagnosed with BPD and the group that was not diagnosed with BPD.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelley Z Kovatis, MD	ChristianaCare	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Services, Inc		Newark	Delaware	19718	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001997	Bronchopulmonary Dysplasia
D047928	Premature Birth

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

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Browse Branches

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