Neonatal Non-Invasive Hemoglobin Determination | NCT01335919

Studies
Neonatal Non-Invasive Hemoglobin Determination

NCT01335919

Sponsor

Children's Hospital of Philadelphia

Status

Withdrawn

Last Update Posted

Jan 8, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Surgical Procedures
Infant, Newborn
Infant, Low Birth Weight

Interventions

Not provided

Countries

Not provided

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

Jan 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Company is redesigning measuring tool.

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Feb 2, 2011

First Submission Date that Met QC Criteria

Apr 14, 2011

First Posted Date

Apr 15, 2011Estimated

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

Jan 7, 2013

Last Update Posted Date

Jan 8, 2013Estimated

Name	Class
Masimo Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 evaluate hemoglobin (Hgb) measurement by Masimo-developed pulse co-oximetry in pediatric patients weighing less than 3 kilograms (Kg).

Detailed Description

This collaborative study with Masimo Corporation will involve 2 phases. In the first phase of this study, 25 subjects weighing 0.5 to 3.0 kg will be recruited and hemoglobin values will be obtained from the non-invasive probe at the same time as blood samples are routinely drawn for Hgb analysis using the cyanomethemoglobin method (ADVIA 2121). Masimo Corporation will use this data to calibrate or modify the hemoglobin reading (SpHb®) sensors and monitors. All results and conclusions from this phase will be discussed with the investigation team in order to determine if additional subjects are needed (at increments of 25 subjects at a time). Once the sensor designs have been optimized, another group of patients will be studied to document the accuracy and precision of the hemoglobin reading (SpHb®) measurements.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neonate		Subjects admitted for surgery or to the pediatric intensive care unit (PICU) or neonatal intensive care unit (NICU) who require daily and/or multiple blood samples for hemoglobin measurement.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®)	The primary endpoint is comparing at least one simultaneous non-invasive, photoplethysmographic, hemoglobin reading (SpHb®) and one invasive hemoglobin measurements (Hb) for each subject. (SpHb® vs. Hb)	up to 5 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females weighing 0.5 kg to 3 kg.
Neonates and infants and children admitted to the Children's Hospital of Philadelphia (CHOP)operating room (OR), PICU and NICU where hemoglobin measurements are anticipated.
Parental/guardian permission (informed consent)

Exclusion Criteria:

Subjects where blood samples are obtained through access types other than venous or arterial (e.g: intraosseous).
Subject weighing more than 3 kg.
Subjects who are too small or with any anatomical limitations that would preclude proper attachment of the adhesive sensor.
Any skin rash on the intended site of measurement. Severe allergy to adhesive tapes.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Year

Standard Ages

Child

Study Population

Neonates admitted for a surgical procedure or admitted to the PICU or NICU where hemoglobin determinations are expected.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denis Jablonka, MD	Children's Hospital of Philadelphia	Principal Investigator

Locations

Not provided