Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates

Neonatal Thrombocytopenia Clinical Trial

Official title:

Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02802982
• Other study ID #: IRB-P00005413
• Secondary ID: 5R01HL069990-11
• Status: Active, not recruiting
• Start date: April 2013
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 28
• Est. completion date: December 2024
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Days to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Thrombocytopenia
• Thrombocytopenia

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Children's Hospital	Boston	Massachusetts
United States	The University of Iowa	Iowa City	Iowa

Sponsors (5)

Lead Sponsor	Collaborator
Boston Children's Hospital	Beth Israel Deaconess Medical Center, National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of the duration of thrombocytopenia in neonates.	to develop clinically useful parameters to predict the duration of thrombocytopenia in neonates, using mathematical modeling.	3 years