Brief Title
Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates
Official Title
Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates
Brief Summary
Parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent
to enter the study. For the purposes of the study, thrombocytopenia will be defined as a
platelet count <60,000/uL or a platelet count <100,000/uL that prompted a platelet
transfusion. Following enrollment, the platelet count will be followed in each infant.
Participants will enter the study if on day 5 or later after the onset of thrombocytopenia
(defined as above) infants either have a platelet count <60,000/uL or a platelet count
<100,000/uL for which a platelet transfusion is ordered.
Detailed Description
Parents of infants who have been thrombocytopenic for 3-4 days will be approached for consent
to enter the study. For the purposes of the study, thrombocytopenia will be defined as a
platelet count <60,000/uL or a platelet count <100,000/uL that prompted a platelet
transfusion. Following enrollment, the platelet count will be followed in each infant.
Participants will enter the study if, on day 5 or later after the onset of thrombocytopenia
(defined as above), infants either have a platelet count <60,000/uL or a platelet count
<100,000/uL for which a platelet transfusion is ordered. If criteria are met, eligible
infants will have a single blood sample drawn (approx. 800 mcL total) for a complete blood
count with Immature Platelet Fraction (IPF) and for determination of a panel of factors
important in the regulation of thrombopoiesis (including TPO, IL-6, IL-11, IL-3, PF-4, VEGF,
HGF, PDGF, and Epo). Importantly, in patients who are being transfused for platelet counts
<100,000/uL, this sample will need to be obtained immediately prior to the platelet
transfusion. If the patient has a platelet count <60,000/uL and is not being transfused, the
blood can be obtained at any time.
Following this initial sample, a platelet count with IPF will be obtained any time a CBC is
ordered for clinical indications, using left-over blood stored in the clinical laboratory for
<24 hrs (only 100 mcL are needed for this). In addition, left-over blood from clinically
indicated studies will be collected from the clinical laboratory, processed and stored at
-80C for future cytokine studies. Samples will continue to be collected and serial platelet
counts with IPF followed until resolution of the thrombocytopenia, defined as a platelet
count >60,000/uL for five days without platelet transfusions.
In addition, research nurses will collect and record the infants' demographic data (including
gestational age, days of life, birth weight), diagnoses, clinical condition at the time of
study entry (respiratory and/or hemodynamic support), time and volume of platelet
transfusions, coagulation tests, liver enzymes, and tests of kidney function. Moderate and
severe bleeding will also be recorded, using criteria defined a priori.
Study Type
Observational
Primary Outcome
Prediction of the duration of thrombocytopenia in neonates.
Condition
Neonatal Thrombocytopenia
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
28
Start Date
April 2013
Completion Date
December 2021
Primary Completion Date
December 2016
Eligibility Criteria
Inclusion Criteria:
1. Are admitted to one of the participating NICUs or the CICU at BCH;
2. Have a post-conceptional age (gestational age + age in weeks) between 23 and 48 weeks;
and
3. Have had thrombocytopenia, defined as a platelet count <60,000/uL or a platelet count
<100,000/uL but receiving platelet transfusions, for ≥ 5 days.
Exclusion Criteria:
1. Are on ECMO; or
2. Are not expected to survive by the attending neonatologist.
Gender
All
Ages
N/A - 3 Months
Accepts Healthy Volunteers
No
Contacts
Martha Sola-Visner, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02802982
Organization ID
IRB-P00005413
Secondary IDs
5R01HL069990-11
Responsible Party
Principal Investigator
Study Sponsor
Boston Children's Hospital
Collaborators
Beth Israel Deaconess Medical Center
Study Sponsor
Martha Sola-Visner, MD, Principal Investigator, Boston Children's Hospital
Verification Date
January 2021