Neonatal Non-Invasive Hemoglobin Determination

NCT01335919 | Withdrawn

• 1 other identifier: 10-007757
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Surgical Procedures; Infant, Newborn; Infant, Low Birth Weight

Keywords

Hemoglobin; Monitoring, Physiologic; Blood Gas Monitoring, Transcutaneous

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Masimo Corporation: collaborator

Study Officials

• Denis Jablonka, MD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2011
• First Posted: April 15, 2011
• Study Start: September 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 8, 2013

Record last verified: 2013-01