Bronchopulmonary DysplasiaNCT05053269
Body Weight Growth After Birth and Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia and Preterm, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. Read more about this study
- Who is it for?
- Ages 1 minute to 1 day
- Conditions the study is for
- Bronchopulmonary Dysplasia, Preterm
- What is being tested?
- good body weight growth and poor body weight growth
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 31 Dec 2024
- 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 1 minute to 1 day
- All sexes
- Child
Study population: the preterm infants' gestational age is equal to or less than 32 weeks will be included in the study
Who may be able to join
- equal to or less than 32 weeks' gestational age
Who cannot join
- main congenital malformation
- parents' refusal
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400042
About this study
Official title: Association of Body Weight Growth After Birth and Bronchopulmonary Dysplasia(BPD)
Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.
Read the detailed description
Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.
The aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.
- Conditions
- Bronchopulmonary Dysplasia, Preterm
- Being tested
- good body weight growth, poor body weight growth
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
good body weight growthOther
body weight growth after birth is consistent with the growth curve
poor body weight growthOther
body weight growth after birth is inconsistent with the growth curve
| Study group | Role | What they receive |
|---|---|---|
| good body weight growth | body weight growth after birth is consistent with the growth curve Receives: Other: good body weight growth | |
| poor body weight growth | body weight growth after birth is inconsistent with the growth curve Receives: Other: poor body weight growth |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of BPD
the infant was diagnosed with BPD
Measured: up to 36 weeks' gestational age
Secondary outcomes (1)
body weight growth after birth
to assess whether body weight growth after birth is consistent with the growth curve
Measured: up to 36 weeks' gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: none was included
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Responsible party
- Principal investigator, Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053269
- Sponsor's protocol ID
- 2020228
- Status last verified
- Oct 2022
- First submitted
- 12 Sep 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Body Weight Growth After Birth and Bronchopulmonary Dysplasia(BPD)
- ClinicalTrials.gov ID
- NCT05053269
- Acronym / sponsor ID
- 2020228
- Conditions
- Bronchopulmonary Dysplasia, Preterm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: none was included
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Chongqing Medical University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Sep 2021 (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 (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.
Detailed description
Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.
The aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| good body weight growth | – | Other: good body weight growthbody weight growth after birth is consistent with the growth curve |
| poor body weight growth | – | Other: poor body weight growthbody weight growth after birth is inconsistent with the growth curve |
Who may qualify
- Ages
- 1 minute to 1 day
- Sex
- All
- Age groups
- Child
- Study population
- the preterm infants' gestational age is equal to or less than 32 weeks will be included in the study
Key inclusion criteria (1 listed)
- equal to or less than 32 weeks' gestational age
Key exclusion criteria (2 listed)
- main congenital malformation
- parents' refusal
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 |
|---|---|---|
| good body weight growthbody weight growth after birth is consistent with the growth curve | Other | good body weight growth |
| poor body weight growthbody weight growth after birth is inconsistent with the growth curve | Other | poor body weight growth |
Primary outcome
the incidence of BPD
Time frame: up to 36 weeks' gestational age
the infant was diagnosed with BPD
1 secondary outcome
body weight growth after birth
Time frame: up to 36 weeks' gestational age
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: Undecided
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
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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.
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 Preterm, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 1 May 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
the incidence of BPD (time frame: up to 36 weeks' gestational age). 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 1 May 2023.