Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

NCT00917007 | Withdrawn

• 1 other identifier: IRBPHS #5803
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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 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.

Conditions

ABO Incompatibility; Hemolytic Disease of Newborn; Neonatal Jaundice; Neonatal Hyperbilirubinemia

Keywords

ABO incompatibility; hemolysis; jaundice; hyperbilirubinemia; newborn

Study Arms (3)

ABO compatible

ABO incompatible, antiglobulin positive

ABO incompatible, antiglobulin negative

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

healthy term newborn infants of mothers with type O blood type

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• New York State Department of Health: collaborator
• Laboratory Alliance of Central New York: collaborator
• Stanford University: collaborator

Study Sites (2)

Crouse Hospital

Syracuse, New York, 13210, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Erythroblastosis, Fetal; Jaundice, Neonatal; Hyperbilirubinemia, Neonatal; Hemolysis; Jaundice; Hyperbilirubinemia

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Richard H Sills, MD

  SUNY Upstate Medical Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

US (2)