Mathematical Modeling to Predict the Duration of Thrombocytopenia in Neonates

NCT02802982 | Active Not Recruiting

• 2 other identifiers: IRB-P000054135R01HL069990-11
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Neonatal Thrombocytopenia

Keywords

Thrombocytopenia; Neonates

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 5 Days - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants who have been thrombocytopenic for 5 days will be approached for the study.

You may qualify if:

• Are admitted to one of the participating NICUs or the CICU at BCH;
• Have a post-conceptional age (gestational age + age in weeks) between 23 and 48 weeks; and
• 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.

You may not qualify if:

• Are on ECMO; or
• Are not expected to survive by the attending neonatologist.

Sponsors & Collaborators

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

Study Sites (3)

The University of Iowa

Iowa City, Iowa, 52242, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

A single blood sample drawn (approx. 800 mcL total) for a complete blood count with 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, IGF-1, IGF-II, TGF-ß, HGF, PDGF, and Epo). 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.

MeSH Terms

Conditions

Thrombocytopenia, Neonatal Alloimmune; Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Martha Sola-Visner, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 14, 2016
• First Posted: June 16, 2016
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)