WithdrawnNot Applicable

Neonatal Non-Invasive Hemoglobin Determination

Stopped: Company is redesigning measuring tool.

0Started 2011-09

Plain-language 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).

Who can participate

Age range1 Year

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Non-invasive, photoplethysmographic, hemoglobin reading (SpHb®)

Timeframe: up to 5 minutes

Trial details

NCT IDNCT01335919

SponsorChildren's Hospital of Philadelphia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-12

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