Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia
BPD
1 other identifier
observational
96
1 country
1
Brief Summary
To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2019
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 16, 2020
CompletedApril 16, 2020
April 1, 2020
1 year
March 15, 2020
April 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Platelet counts and Circulating MK counts
Platelet counts and Circulating MK counts
up to 4 weeks
Secondary Outcomes (3)
CD62P and CD63 expression
up to 4 weeks
TPO
up to 4 weeks
TPO and platelet
up to 6 weeks
Study Arms (2)
BPD group
premature infants diagnosed with BPD after postnatal day 28
control group
premature infants without BPD after postnatal day 28
Interventions
Eligibility Criteria
Bronchopulmonary dysplasia (BPD) is one of the common complications in neonatal intensive care units (NICU), mainly occurs in premature infants and is considered to be the main cause of premature death
You may qualify if:
- presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992);
- presence of peripheral arterial catheter;
- gestation \<32 weeks;
- birth weight \<1.5 kg;
- requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life;
- ventilator and/or oxygen dependent at time of enrolment;
You may not qualify if:
- congenital abnormalities;
- infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture)
- evidence of complications of perinatal asphyxia including an apgar score \<3 at one or five minute after birth, evidence of hypoxic-ischemic encephalopathy, acute tubular necrosis, or transient myocardial ischemia;
- identifiable hematologic disease;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- yangjielead
Study Sites (1)
Jie Yang
Guangzhou, Guangdong, 511442, China
Biospecimen
Peripheral arterial blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of Dept of Neonatology
Study Record Dates
First Submitted
March 15, 2020
First Posted
April 16, 2020
Study Start
January 1, 2019
Primary Completion
January 1, 2020
Study Completion
January 1, 2020
Last Updated
April 16, 2020
Record last verified: 2020-04