Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
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Purpose
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.
| Condition |
|---|
|
ABO Incompatibility Hemolytic Disease of Newborn Neonatal Jaundice Neonatal Hyperbilirubinemia |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis in ABO-compatible and Incompatible Healthy Term Newborn Infants. |
whole blood
| Estimated Enrollment: | 120 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| ABO compatible |
| ABO incompatible, antiglobulin positive |
| ABO incompatible, antiglobulin negative |
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, 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.
Eligibility| Ages Eligible for Study: | up to 28 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
healthy term newborn infants of mothers with type O blood type
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
Contacts and Locations| Contact: Richard H Sills, MD | 315-464-5294 | sillsr@upstate.edu |
| Contact: Pasaka Griciene, MD | 315-464-7536 | gricienp@upstate.edu |
| United States, New York | |
| SUNY Upstate Medical University | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Richard H Sills, MD 315-464-5294 sillsr@upstate.edu | |
| Contact: Pasaka Griciene, MD 315-464-7536 gricienp@upstate.edu | |
| Crouse Hospital | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Richard H Sills, MD 315-464-5294 sillsr@upstate.edu | |
| Principal Investigator: | Richard H Sills, MD | SUNY Upstate Medical Univeristy |
More Information
No publications provided
| Responsible Party: | Richard H. Sills, MD, SUNY Upstate Medical University Dept of Pediatrics |
| ClinicalTrials.gov Identifier: | NCT00917007 History of Changes |
| Other Study ID Numbers: | IRBPHS #5803 |
| Study First Received: | June 8, 2009 |
| Last Updated: | August 4, 2010 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by State University of New York - Upstate Medical University:
|
ABO incompatibility hemolysis jaundice hyperbilirubinemia newborn |
Additional relevant MeSH terms:
|
Erythroblastosis, Fetal Hemolysis Hyperbilirubinemia Jaundice Jaundice, Neonatal Hyperbilirubinemia, Neonatal Fetal Diseases Pregnancy Complications |
Blood Group Incompatibility Hematologic Diseases Infant, Newborn, Diseases Immune System Diseases Pathologic Processes Skin Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013