Neonates PrematurePhase 1BPDNCT03855202
The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
A Phase 1 study testing CBMNC, PS+CBMNC and PS in people with Neonates Premature and Ventilator Support, run by yangjie.
Trial summary
Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. Read more about this study
- Who is it for?
- Ages 28 to 36 weeks
- Conditions the study is for
- Neonates Premature, Ventilator Support
- What is being tested?
- CBMNC, PS+CBMNC and PS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 24 Feb 2019to 20 Aug 2020
- Phase
- Phase 1
- 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 28 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- twenty-eight weeks to thirty-seven weeks
Who cannot join
- Pretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
Trial locations and contacts
No sites are listed yet.
About this study
Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems
Read the detailed description
This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.
- Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)
- Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
- Demographic Data and Baseline characteristics of the study groups were collected:
Gestational age(weeks) birth weight(g) gender Cesarean section delivery antenatal steroids prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP befor intervention(mg/l) TNF-αbefore intervention（pg/ml） 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m，3m，6m,1y:neurodevelopment,asthma，anemia and physic growth
- Conditions
- Neonates Premature, Ventilator Support
- Being tested
- CBMNC, PS+CBMNC, PS, Placeo
- Keywords
- PS, cord blood mononuclaer Cells, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBMNCBiological
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
PS+CBMNCBiological
autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
PSBiological
PS,dose is 70mg/kg
PlaceoOther
0.9% sodium chloride installation after 24 hours
| Study group | Role | What they receive |
|---|---|---|
| infusion froup 1 | Experimental | autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg Receives: Biological: CBMNC |
| infusion group 2 | Experimental | autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg Receives: Biological: PS+CBMNC |
| infusion group 3 | Experimental | PS,dose is 70mg/kg Receives: Biological: PS |
| Placebol | Placebo comparator | 0.9% sodium chloride installation after 24 hours Receives: Other: Placeo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients who died
mority rate
Measured: up to 21 days after birth
Secondary outcomes (1)
number of patients with neurodevelopmental disorder assessed by Bayley Score
Long term follow up:in 1 month, 3months,6 months,and 1 years:
Measured: up to 1 month, 3 month, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start24 Feb 2019 (estimated)
- Primary completion1 Aug 2019 (estimated)
- Study completion20 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates PrematureStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- yangjie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yangjie, Guangdong Women and Children Hospital
- Investigators
- Jie Yang, PHD, Principal investigator, Guangdong Women and Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855202
- Sponsor's protocol ID
- Guangdong W C H
- Acronym
- BPD
- Status last verified
- Feb 2019
- First submitted
- 24 Feb 2019
- Last updated
- 26 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Bronchopulmonary Dysplasia by Instillation PS and Mononuclaer Cells in Preterms
- ClinicalTrials.gov ID
- NCT03855202
- Acronym / sponsor ID
- BPD / Guangdong W C H
- Conditions
- Neonates Premature, Ventilator Support
- Keywords
- PS, cord blood mononuclaer Cells, preterm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- yangjieUniversity, hospital or other
- Study start
- 24 Feb 2019 (estimated)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 20 Aug 2020 (estimated)
- First posted
- 26 Feb 2019 (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.
Bronchopulmonary dysplasia mainly occurs in premature infants, which is the main cause of premature infant death.If children with BPD can survive, they are also prone to complications of long-term respiratory diseases such as asthma,that affect the quality of life of BPD children. However, there is no effective treatment method for BPD. So,the investigator would like to investigate the effect of Intratracheal PS and mononuclaer cells in pretems
Detailed description
This is a Phase 1 clinical trial that constitues one time points cohor and three group,each group with 80 participants,which receive intratracheal PS and mononuclaer cells,receive intratracheal PS,receive intratracheal mononuclaer cells.
- Eligibility Criteria:Preterm(gestational age more than 28weeks and less than 37weeks)
- Exlusion criteria: Preterm infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
- Demographic Data and Baseline characteristics of the study groups were collected:
Gestational age(weeks) birth weight(g) gender Cesarean section delivery antenatal steroids prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes Thrombocytopenia before intervention CRP befor intervention(mg/l) TNF-αbefore intervention（pg/ml） 4.Autologous cord blood mononuclear cells doses is 25million cells/kg 5.the following are monitored at 3、7、14、21 days after birth: mortality, incidence of bronchopulmonary dysplasia 5.Long-term follow up:in 1m，3m，6m,1y:neurodevelopment,asthma，anemia and physic growth
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| infusion froup 1 | Experimental | Biological: CBMNCautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg |
| infusion group 2 | Experimental | Biological: PS+CBMNCautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg |
| infusion group 3 | Experimental | Biological: PSPS,dose is 70mg/kg |
| Placebol | Placebo comparator | Other: Placeo0.9% sodium chloride installation after 24 hours |
Who may qualify
- Ages
- 28 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- twenty-eight weeks to thirty-seven weeks
Key exclusion criteria (1 listed)
- Pretem infants with major congenital malformations,chromosomal anomalies,inborn errors of metabolism and clinical or laboratory evidence of a congenital infection
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 |
|---|---|---|
| CBMNCautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg | Biological | infusion froup 1 |
| PS+CBMNCautologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg | Biological | infusion group 2 |
| PSPS,dose is 70mg/kg | Biological | infusion group 3 |
| Placeo0.9% sodium chloride installation after 24 hours | Other | Placebol |
Primary outcome
number of patients who died
Time frame: up to 21 days after birth
mority rate
1 secondary outcome
number of patients with neurodevelopmental disorder assessed by Bayley Score
Time frame: up to 1 month, 3 month, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Jie Yang, PHD principal investigator
Guangdong Women and Children Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CBMNC, PS+CBMNC and PS in people with Neonates Premature and Ventilator Support, run by yangjie.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhuxiao Ren, MD (+8613538984634, renzhx1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who died (time frame: up to 21 days after birth). 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 26 Feb 2019.