Bronchopulmonary DysplasiaBPDNCT04348799
Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia
An observational study of Bronchopulmonary Dysplasia and Thrombocytopenia, run by yangjie at 1 site in China.
Trial summary
To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Thrombocytopenia, Preterm Infant
- What is being tested?
- BPD
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the relationship between bronchopulmonary dysplasia and thrombocytopenia.
Read the 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.
- Conditions
- Bronchopulmonary Dysplasia, Thrombocytopenia, Preterm Infant
- Being tested
- BPD
- Medical subject headings
- Bronchopulmonary Dysplasia, Thrombocytopenia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPDOther
It is a observation research.we didn't intervene anything.
| Study group | Role | What they receive |
|---|---|---|
| BPD group | premature infants diagnosed with BPD after postnatal day 28 Receives: Other: BPD | |
| control group | premature infants without BPD after postnatal day 28 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet counts and Circulating MK counts
Platelet counts and Circulating MK counts
Measured: up to 4 weeks
Secondary outcomes (3)
CD62P and CD63 expression
CD62P and CD63 expression
Measured: up to 4 weeks
TPO
Plasma TPO concentration
Measured: up to 4 weeks
TPO and platelet
the relationship betweenTPO concentration and Platelet counts in BPD with thrombocytopenia
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- yangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yangjie, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348799
- Sponsor's protocol ID
- Guangdong W C H
- Acronym
- BPD
- Status last verified
- Apr 2020
- First submitted
- 15 Mar 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thrombocytopoiesis and Platelet Homeostasis in Infants With Bronchoplumonary Dysplasia
- ClinicalTrials.gov ID
- NCT04348799
- Acronym / sponsor ID
- BPD / Guangdong W C H
- Conditions
- Bronchopulmonary Dysplasia, Thrombocytopenia, Preterm Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- yangjieUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPD group | – | Other: BPDpremature infants diagnosed with BPD after postnatal day 28 |
| control group | – | –premature infants without BPD after postnatal day 28 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BPDIt is a observation research.we didn't intervene anything. | Other | BPD group |
Primary outcome
Platelet counts and Circulating MK counts
Time frame: up to 4 weeks
Platelet counts and Circulating MK counts
3 secondary outcomes
CD62P and CD63 expression
Time frame: up to 4 weeks
TPO
Time frame: up to 4 weeks
TPO and platelet
Time frame: up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia and Thrombocytopenia, run by yangjie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet counts and Circulating MK counts (time frame: up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.