Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia

Completed

• Conditions: Preterm Infant; Bronchopulmonary Dysplasia; Thrombocytopenia
• Interventions: Other: BPD

• Registration Number: NCT04348799
• Lead Sponsor: yangjie

Brief Summary

To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

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 Timeline

• Study Start: 2019-01-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-01
• Study First Submitted: 2020-03-15
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BPD group	BPD	premature infants diagnosed with BPD after postnatal day 28

Primary Outcome Measures

Name	Time	Method
Platelet counts and Circulating MK counts	up to 4 weeks	Platelet counts and Circulating MK counts

Secondary Outcome Measures

Name	Time	Method
CD62P and CD63 expression	up to 4 weeks	CD62P and CD63 expression
TPO	up to 4 weeks	Plasma TPO concentration
TPO and platelet	up to 6 weeks	the relationship betweenTPO concentration and Platelet counts in BPD with thrombocytopenia

Trial Locations

Locations (1)

Jie Yang; 🇨🇳 Guangzhou, Guangdong, China