ABO IncompatibilityNCT00917007
Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis
An observational study of ABO Incompatibility and Hemolytic Disease of Newborn, run by State University of New York - Upstate Medical University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- ABO Incompatibility, Hemolytic Disease of Newborn, Neonatal Jaundice
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: healthy term newborn infants of mothers with type O blood type
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Crouse Hospital
Syracuse, New York, 13210
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis in ABO-compatible and Incompatible Healthy Term Newborn Infants.
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.
Read the 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.
- Conditions
- ABO Incompatibility, Hemolytic Disease of Newborn, Neonatal Jaundice, Neonatal Hyperbilirubinemia
- Keywords
- ABO incompatibility, hemolysis, jaundice, hyperbilirubinemia, newborn
- Medical subject headings
- Erythroblastosis, Fetal, Jaundice, Neonatal, Hyperbilirubinemia, Neonatal, Hemolysis, Jaundice, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ABO compatible | Not described | |
| ABO incompatible, antiglobulin positive | Not described | |
| ABO incompatible, antiglobulin negative | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: PI no longer at institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ABO IncompatibilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Department of Health, Laboratory Alliance of Central New York, Stanford University
- Investigators
- Richard H Sills, MD, Principal investigator, SUNY Upstate Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917007
- Sponsor's protocol ID
- IRBPHS #5803
- Status last verified
- Oct 2021
- First submitted
- 8 Jun 2009
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Carboxyhemoglobin by Gas Chromatography as an Index of Hemolysis in ABO-compatible and Incompatible Healthy Term Newborn Infants.
- ClinicalTrials.gov ID
- NCT00917007
- Acronym / sponsor ID
- IRBPHS #5803
- Conditions
- ABO Incompatibility, Hemolytic Disease of Newborn, Neonatal Jaundice, Neonatal Hyperbilirubinemia
- Keywords
- ABO incompatibility, hemolysis, jaundice, hyperbilirubinemia, newborn
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: PI no longer at institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- New York State Department of Health, Laboratory Alliance of Central New York, Stanford University
- Study start
- Jun 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ABO compatible | – | – |
| ABO incompatible, antiglobulin positive | – | – |
| ABO incompatible, antiglobulin negative | – | – |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- healthy term newborn infants of mothers with type O blood type
Key inclusion criteria (7 listed)
- written informed consent
- mother blood type O
- mother Rh +
- healthy infants
- ≥37 wks gestation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
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The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard H Sills, MD principal investigator
SUNY Upstate Medical Univeristy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ABO Incompatibility and Hemolytic Disease of Newborn, run by State University of New York - Upstate Medical University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.