NCT04348799

Brief Summary

To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2020

Completed
Last Updated

April 16, 2020

Status Verified

April 1, 2020

Enrollment Period

1 year

First QC Date

March 15, 2020

Last Update Submit

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

Other: BPD

control group

premature infants without BPD after postnatal day 28

Interventions

BPDOTHER

It is a observation research.we didn't intervene anything.

BPD group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

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

Study Sites (1)

Jie Yang

Guangzhou, Guangdong, 511442, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral arterial blood

MeSH Terms

Conditions

Bronchopulmonary DysplasiaThrombocytopeniaPremature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBlood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopeniaObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

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

Locations