Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

— BPD  

Official title:

Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04348799
• Other study ID #: Guangdong W C H
• Status: Completed
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: April 2020
• Source: Guangdong Women and Children Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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;

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Preterm Infant
• Thrombocytopenia

Intervention

Other:
• BPD
It is a observation research.we didn't intervene anything.

Locations

Country	Name	City	State
China	Jie Yang	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
yangjie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet counts and Circulating MK counts	Platelet counts and Circulating MK counts	up to 4 weeks
Secondary	CD62P and CD63 expression	CD62P and CD63 expression	up to 4 weeks
Secondary	TPO	Plasma TPO concentration	up to 4 weeks
Secondary	TPO and platelet	the relationship betweenTPO concentration and Platelet counts in BPD with thrombocytopenia	up to 6 weeks