ThrombocytopeniaNCT00333333
Mechanism of Thrombocytopenia in Infants
An observational study of Thrombocytopenia and Small for Gestational Age (SGA), run by Christiana Care Health Services at 1 site in United States.
Trial summary
This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thrombocytopenia, Small for Gestational Age (SGA), Preeclampsia
- What is being tested?
- Cord blood
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jun 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia
Who may be able to join
- Infants who are less than 34 weeks gestation
- Infants born to mothers with preeclampsia
- Infants who are born small for gestational age whose mother did not have preeclampsia
Who cannot join
- Infants who are greater than 34 weeks gestation
- Infants with known congenital anomalies or known congenital infections
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health Systems
Newark, Delaware, 19713
About this study
Official title: Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure
This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.
Read the detailed description
Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.
- Being tested
- Cord blood
- Keywords
- Thrombocytopenia, Small for Gestational Age (SGA), Preeclampsia
- Medical subject headings
- Thrombocytopenia, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord bloodProcedure or surgery
Cord blood will be obtained at the time of delivery.
| Study group | Role | What they receive |
|---|---|---|
| SGA infants | Infants who are thought to be small for gestational age (SGA) Receives: Procedure: Cord blood | |
| Pre-eclampsia exposed | Infants who are born to mothers who had pre-eclampsia Receives: Procedure: Cord blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure
Measured: Each infant will only be enrolled during the time of birth until cord blood is collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Collaborators
- The Cardeza Foundation for Hematologic Research
- Investigators
- Kelly Zook, MD, Principal investigator, Christiana Care Health Systems; Thomas Jefferson University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333333
- Sponsor's protocol ID
- CCC# 26075
- Status last verified
- Jun 2008
- First submitted
- 2 Jun 2006
- Last updated
- 13 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Thrombocytopenia in Small for Gestational Age Infants Versus Infants With Maternal Preeclampsia Exposure
- ClinicalTrials.gov ID
- NCT00333333
- Acronym / sponsor ID
- CCC# 26075
- Keywords
- Thrombocytopenia, Small for Gestational Age (SGA), Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Collaborators
- The Cardeza Foundation for Hematologic Research
- Study start
- Jun 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Jun 2006 (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.
This research project is studying the causes for low platelet levels in preterm infants. Platelets are a component of blood that helps with clotting. The purpose of this study is to determine whether the cause for low platelet levels is the same in infants who are born to mothers with preeclampsia and infants who are small for gestational age.
Detailed description
Thrombocytopenia is a common entity in infants who are born to mothers with preeclampsia and in infants who are small for gestational age. There have been several theories to the mechanism underlying thrombocytopenia in these groups of patients. One mechanism suggests that thrombocytopenia in these populations may be secondary to underproduction of platelets. Other studies have implied that low platelet levels may be due to endothelial activation causing platelet consumption. This study is being performed to help determine the mechanism causing thrombocytopenia in infants born to mothers with preeclampsia and comparing it to the mechanism of thrombocytopenia in infants who are small for gestational age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGA infants | – | Procedure: Cord bloodInfants who are thought to be small for gestational age (SGA) |
| Pre-eclampsia exposed | – | Procedure: Cord bloodInfants who are born to mothers who had pre-eclampsia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In utero infants who are small for gestational age or who are exposed to maternal pre-eclampsia
Key inclusion criteria (3 listed)
- Infants who are less than 34 weeks gestation
- Infants born to mothers with preeclampsia
- Infants who are born small for gestational age whose mother did not have preeclampsia
Key exclusion criteria (2 listed)
- Infants who are greater than 34 weeks gestation
- Infants with known congenital anomalies or known congenital infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord bloodCord blood will be obtained at the time of delivery. | Procedure or surgery | Pre-eclampsia exposed, SGA infants |
Primary outcome
To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure
Time frame: Each infant will only be enrolled during the time of birth until cord blood is collected.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2008.
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rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
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A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
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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.
Kelly Zook, MD principal investigator
Christiana Care Health Systems; Thomas Jefferson University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytopenia and Small for Gestational Age (SGA), run by Christiana Care Health Services at 1 site 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
To determine the mechanism of thrombocytopenia in small for gestational age infants versus infants with maternal preeclampsia exposure (time frame: Each infant will only be enrolled during the time of birth until cord blood is collected.). It is what the study was designed to measure, not a finding.
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 13 Jun 2008.