WithdrawnNot Applicable

Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

Stopped: PI no longer at institution

United States0Started 2009-06

Plain-language summary

The purpose of this research study is to more accurately measure the amount of true red blood cell breakdown (hemolysis) in newborn babies with potentially problematic blood type mismatch with their mothers (ABO incompatibility), and to examine how the true level of red blood cell destruction relates to other laboratory tests obtained in newborns with jaundice. A better understanding of the true amount of red blood cell destruction that is caused by blood type mismatch, as well as how it relates with other laboratory tests ordered for ABO incompatibility and red blood cell destruction, would help avoid unnecessary testing, treatment and prolonged hospital stays in such babies.

Who can participate

Age range28 Days

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: * written informed consent * mother blood type O * mother Rh + * healthy infants * ≥37 wks gestation * ≥ 2500 gm birth weight * Apgar ≥5 at 1 and 5 minutes Exclusion Criteria: * major anomalies * infants evaluated for sepsis or infants with transitional respiratory problems requiring \>6 hrs observation in the NICU * significant birth trauma with continued bruising and/or sequestration of blood still evident at the time of discharge * known perinatal blood loss with hemodynamic consequences such as persistent tachycardia, need for fluid boluses or supplemental oxygen * neonatal anemia with Hb\<13.5g/dL * known family history of hereditary hemolytic disease such as G6PD deficiency, hereditary spherocytosis or hereditary elliptocytosis

Trial details

NCT IDNCT00917007

SponsorState University of New York - Upstate Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-11