View Clinical Trial (Medical Research Study)
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis in ABO-compatible and Incompatible Healthy Term Newborn Infants.
| City: |
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Syracuse |
| State: |
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New York |
| Zip Code: |
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13210 |
| Conditions: |
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ABO Incompatibility - Hemolytic Disease of Newborn - Neonatal Jaundice - Neonatal Hyperbilirubinemia |
| Purpose: |
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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.
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| Study Summary: |
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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, but only a very small proportion of blood type A or B babies born to O type
mothers develop overt ABO hemolytic disease. Despite the relative rarity of ABO hemolytic
disease, it is common practice among pediatricians and family practice physicians to perform
routine blood typing and antibody screening on all newborns born to type O mothers.
A very accurate and reliable laboratory measure of red blood cell destruction is the plasma
carboxyhemoglobin level (COHb). COHb levels can be determined using a minute amount of
blood, obtained at the same time the newborn's heel is pierced to obtain blood for the
mandatory newborn screen (performed on all newborns prior to discharge) in order to avoid an
additional invasive procedure.
Our hope is to determine whether routine blood typing and anti-globulin testing of infants
born to type O mothers is necessary, or if these tests should instead be obtained only in
the context of significant visible jaundice. This would help clarify the proper management
of a very common problem in the newborn, and minimize the potential for subjecting infants
of type O mothers to unnecessary blood tests, unwarranted treatment, and prolonged
hospitalizations.
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| Criteria: |
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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
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| NCT ID: |
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NCT00917007 |
| Primary Contact: |
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Principal Investigator
Richard H Sills, MD
SUNY Upstate Medical Univeristy
Richard H Sills, MD
Phone: 315-464-5294
Email: sillsr@upstate.edu
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| Backup Contact: |
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Email: gricienp@upstate.edu
Pasaka Griciene, MD
Phone: 315-464-7536
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| Location Contact: |
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Syracuse, New York 13210
United States
Richard H Sills, MD
Phone: 315-464-5294
Email: sillsr@upstate.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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