Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates

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