Pulse Oximetry Measurement and Transfusions | NCT04249193

Studies
Pulse Oximetry Measurement and Transfusions

NCT04249193

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Mar 13, 2020Actual

Enrollment

75Actual

Phase

Not provided

Conditions

Hypoxia Neonatal
Premature
Blood Transfusion

Interventions

Transfusion

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

Mar 2020

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

Apr 2014Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Jan 24, 2020

First Submission Date that Met QC Criteria

Jan 29, 2020

First Posted Date

Jan 30, 2020Actual

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

Mar 12, 2020

Last Update Posted Date

Mar 13, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kelley Kovatis, Attending Neonatologist, Christiana Care Health ServicesPrincipal Investigator

Lead Sponsor

Christiana Care Health ServicesOTHER

Collaborators

Name	Class
Temple University Hospital	UNKNOWN
University of Pennsylvania	OTHER
Pennsylvania Hospital	UNKNOWN

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 primary purpose of this observational study was to determine if pRBC transfusions decrease the frequency of intermittent hypoxia events in very low birth weight infants (VLBW) during the first six weeks of life. The impact on non-pRBC transfusions on the frequency of intermittent hypoxia was also assessed.

Detailed Description

Not provided

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

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Transfusion			Other: Transfusion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transfusion	Other	pRBC and non-pRBC transfusions	Transfusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in number of Intermittent hypoxia	An intermittent hypoxemia event is defined as a fall in oxygen saturations to less than 80% for >/= 10 secs and <3 minutes with a minimal time interval of 4 seconds between events.	Change in number of intermittent hypoxia before (approximately 8 hours) and after transfusion (approximately 8 hours).

Secondary Outcomes

Measure	Description	Time Frame
Hypoxia	Percent time with oxygen saturations less than 85%, 80% and 75%.	8 hours prior to transfusion and 8 hours after transfusion.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

23+0 to 28+6 weeks gestational age at birth

Exclusion Criteria:

Infants with life-limiting diagnoses
Cyanotic heart disease
In utero fetal transfusion
Twin to twin transfusion syndrome
Isoimmune hemolytic disease
Severe acute hemorrhage
Acute shock
Sepsis with coagulopathy
Need for perioperative transfusion
Parents opposed to transfusion of blood
Parents with hemoglobinopathy or congenital anemia

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Weeks

Standard Ages

Child

Study Population

Premature neonates

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kelley Z Kovatis, MD	Christiana Care Health Services, Inc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States
Pennsylvania Hospital

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
D001238	Asphyxia Neonatorum
D047928	Premature Birth

Ancestor Terms

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001803	Blood Transfusion

Ancestor Terms

ID	Term
D001691	Biological Therapy
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided