Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia (BPD)

April 14, 2020 updated by: yangjie
To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A prosepective case-control study ,the case were matched with 1:1according to gestational age,birth weight and admission diagnosis and divided into two groups according to the consensus definition of National Institute of Child Health and Human Development (NICHD). Platelet count, circulating megakaryocyte count, platelet activating markers (CD62P and CD63), thrombopoietin were recorded and compared in two groups, then, serial thrombopoietin levels and concomitant platelet counts were measured in infants with BPD.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 511442
        • Jie Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. presence of clinical and radiologic signs of BPD, according to conventional criteria (Greenough, 1992);
  2. presence of peripheral arterial catheter;
  3. gestation <32 weeks;
  4. birth weight <1.5 kg;
  5. requiring mechanical ventilation for the treatment of respiratory distress syndrome for at least 3 days during the first weeks of life;
  6. ventilator and/or oxygen dependent at time of enrolment;

Exclusion Criteria:

  1. congenital abnormalities;
  2. infection (bacteria infection confirmed by positive blood culture or viral infection confirmed by serological test or viral culture)
  3. 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;
  4. identifiable hematologic disease;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BPD group
premature infants diagnosed with BPD after postnatal day 28
Other: BPD
It is a observation research.we didn't intervene anything.
control group
premature infants without BPD after postnatal day 28

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet counts and Circulating MK counts
Time Frame: up to 4 weeks
Platelet counts and Circulating MK counts
up to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD62P and CD63 expression
Time Frame: up to 4 weeks
CD62P and CD63 expression
up to 4 weeks
TPO
Time Frame: up to 4 weeks
Plasma TPO concentration
up to 4 weeks
TPO and platelet
Time Frame: up to 6 weeks
the relationship betweenTPO concentration and Platelet counts in BPD with thrombocytopenia
up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yangjie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 16, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Guangdong W C H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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