MedDataX Logo

Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis

NCT ID: NCT00917007

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

ABO Incompatibility Hemolytic Disease of Newborn Neonatal Jaundice Neonatal Hyperbilirubinemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABO compatible

No interventions assigned to this group

ABO incompatible, antiglobulin positive

No interventions assigned to this group

ABO incompatible, antiglobulin negative

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

Laboratory Alliance of Central New York

UNKNOWN

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

SUNY Upstate Medical University Dept of Pediatrics

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Richard H Sills, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Upstate Medical Univeristy

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Crouse Hospital

Syracuse, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IRBPHS #5803

Identifier Type: -

Identifier Source: org_study_id