Status:
WITHDRAWN
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
New York State Department of Health
Laboratory Alliance of Central New York
Conditions:
ABO Incompatibility
Hemolytic Disease of Newborn
Eligibility:
All Genders
Up to 28 years
Brief 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 m...
Detailed Description
Clinically severe jaundice due to ABO incompatibility can occur when infants with blood type A or B are born to mothers with type O blood. An estimated 20 percent of pregnancies are ABO incompatible, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00917007
Start Date
June 1 2009
End Date
November 1 2010
Last Update
October 25 2021
Active Locations (2)
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1
Crouse Hospital
Syracuse, New York, United States, 13210
2
SUNY Upstate Medical University
Syracuse, New York, United States, 13210