Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by State University of New York - Upstate Medical University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
New York State Department of Health
Laboratory Alliance of Central New York
Stanford University
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00917007
First received: June 8, 2009
Last updated: August 4, 2010
Last verified: August 2010
  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.

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Biospecimen Retention:   Samples With DNA

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
Study Population

healthy term newborn infants of mothers with type O blood type

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917007

Contacts
Contact: Richard H Sills, MD 315-464-5294 sillsr@upstate.edu
Contact: Pasaka Griciene, MD 315-464-7536 gricienp@upstate.edu

Locations
United States, New York
Crouse Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Richard H Sills, MD    315-464-5294    sillsr@upstate.edu   
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   
Sponsors and Collaborators
State University of New York - Upstate Medical University
New York State Department of Health
Laboratory Alliance of Central New York
Stanford University
Investigators
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
Hyperbilirubinemia, Neonatal
Jaundice
Jaundice, Neonatal
Blood Group Incompatibility
Fetal Diseases
Hematologic Diseases
Immune System Diseases
Infant, Newborn, Diseases
Pathologic Processes
Pregnancy Complications
Signs and Symptoms
Skin Manifestations

ClinicalTrials.gov processed this record on October 20, 2014