Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates

• Sponsor: Boston Children's Hospital (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02802982
• Collaborator: Beth Israel Deaconess Medical Center (Other), National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH), University of Iowa (Other)
• Enrollment: 28
• Locations: 3
• Duration (Months): 128
• Patients Per Site: 9.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neonatal Thrombocytopenia

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 Design

• Study Type: Observational
• Actual Enrollment: 28 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Dec 1, 2016
• Anticipated Study Completion Date: Dec 1, 2023

Outcome Measures

Primary Outcome Measures

1. Prediction of the duration of thrombocytopenia in neonates. [3 years]

   to develop clinically useful parameters to predict the duration of thrombocytopenia in neonates, using mathematical modeling.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Days to 3 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Iowa	Iowa City	Iowa	United States	52242
2	Boston Children's Hospital	Boston	Massachusetts	United States	02115
3	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Martha Sola-Visner, MD, Boston Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martha Sola-Visner, MD, Boston Children's Hospital
• ClinicalTrials.gov Identifier: NCT02802982
• Other Study ID Numbers: IRB-P00005413; 5R01HL069990-11
• First Posted: Jun 16, 2016
• Last Update Posted: Mar 10, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Martha Sola-Visner, MD, Boston Children's Hospital: Thrombocytopenia; Neonates
• Additional relevant MeSH terms: Thrombocytopenia; Thrombocytopenia, Neonatal Alloimmune

Study Results

No Results Posted as of Mar 10, 2022