Bronchopulmonary DysplasiaNCT06082414
Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
An observational study of Bronchopulmonary Dysplasia and Death, run by Peking University at 1 site in China.
Trial summary
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China Read more about this study
- Who is it for?
- Ages Up to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Bronchopulmonary Dysplasia, Death
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2019to 29 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 Up to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: infants with a birth weight <1000grams or a gestational age <28 weeks;
Who may be able to join
- born between January 1, 2015, and December 31, 2018;
- a birth weight <1000grams or a gestational age <28 weeks;
- admitted within 72 hours after birth.
Who cannot join
- No medical history in the electronic record
Trial locations and contacts
1 site in 1 country.
About this study
to estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
Read the detailed description
to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
- Conditions
- Bronchopulmonary Dysplasia, Death
- Being tested
- no interventions
- Medical subject headings
- Bronchopulmonary Dysplasia, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
no interventions because of an observational study
| Study group | Role | What they receive |
|---|---|---|
| <28 weeks and <1000 grams | By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. Receives: Other: no interventions | |
| <28 weeks and ≥1000 grams | By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. Receives: Other: no interventions | |
| ≥28 weeks and <1000 grams | By gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidences
to investigate incidences of bronchopulmonary dysplasia
Measured: at 36 weeks' corrected age (CA) or at discharge
risk factors
to investigate risk factors of bronchopulmonary dysplasia
Measured: at 36 weeks' corrected age (CA) or at discharge
incidences of delivery room resuscitation
to investigate incidences of delivery room resuscitation
Measured: on admission
risk factors of delivery room resuscitation
to investigate risk factors of delivery room resuscitation
Measured: on admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start30 Jan 2019
- Primary completion29 Jan 2020
- Study completion29 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Retrospective
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Peking Union Medical College Hospital, Beijing Children's Hospital, Beijing Friendship Hospital, Shanxi Provincial Maternity and Children's Hospital, The Second Hospital of Hebei Medical University, Handan Central Hospital, Xingtai People's Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Children's Hospital of Hebei Province, Tianjin First Central Hospital, Chifeng Municipal Hospital, Tianjin Medical University Second Hospital, PLA Rocket Force Characteristic Medical Center
- Responsible party
- Principal investigator, Li Shuaijun, Peking University
- Investigators
- Qi Feng, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082414
- Sponsor's protocol ID
- 2019(21)
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li S, Feng Q, Huang X, Tian X, Zhou Y, Ji Y, Zhai S, Guo W, Zheng R, Wang H. Association of different doses of antenatal corticosteroids exposure with early major outcomes and early weight loss percentage in extremely preterm infants or extremely low birthweight infants: a multicentre cohort study. BMJ Paediatr Open. 2024 Jun 18;8(1):e002506. doi: 10.1136/bmjpo-2024-002506.
PubMed 38897621
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Management in Extremely Preterm and Extremely Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT06082414
- Acronym / sponsor ID
- 2019(21)
- Conditions
- Bronchopulmonary Dysplasia, Death
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University First Hospital, Peking University People's Hospital, Peking University Third Hospital, Tianjin Central Hospital of Gynecology Obstetrics, Peking Union Medical College Hospital, Beijing Children's Hospital, Beijing Friendship Hospital, Shanxi Provincial Maternity and Children's Hospital, The Second Hospital of Hebei Medical University, Handan Central Hospital, Xingtai People's Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia Medical University, Children's Hospital of Hebei Province, Tianjin First Central Hospital, Chifeng Municipal Hospital, Tianjin Medical University Second Hospital, PLA Rocket Force Characteristic Medical Center
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 29 Jan 2020 (actual)
- Study completion
- 29 Jan 2020 (actual)
- First posted
- 13 Oct 2023 (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 estimate incidences of major complications, such as bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
Detailed description
to estimate incidences and risk factors of bronchopulmonary dysplasia, death, and delivery room resuscitation among extremely preterm and extremely low birth weight infants in Northern China
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| <28 weeks and <1000 grams | – | Other: no interventionsBy gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. |
| <28 weeks and ≥1000 grams | – | Other: no interventionsBy gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. |
| ≥28 weeks and <1000 grams | – | Other: no interventionsBy gestational age and birth weight, infants were classified into 3 groups. No interventions because of an observational study. |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infants with a birth weight <1000grams or a gestational age <28 weeks;
Key inclusion criteria (3 listed)
- born between January 1, 2015, and December 31, 2018;
- a birth weight <1000grams or a gestational age <28 weeks;
- admitted within 72 hours after birth.
Key exclusion criteria (1 listed)
- No medical history in the electronic record
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 |
|---|---|---|
| no interventionsno interventions because of an observational study | Other | <28 weeks and <1000 grams, <28 weeks and ≥1000 grams, ≥28 weeks and <1000 grams |
Primary outcome
incidences
Time frame: at 36 weeks' corrected age (CA) or at discharge
to investigate incidences of bronchopulmonary dysplasia
risk factors
Time frame: at 36 weeks' corrected age (CA) or at discharge
to investigate risk factors of bronchopulmonary dysplasia
incidences of delivery room resuscitation
Time frame: on admission
to investigate incidences of delivery room resuscitation
risk factors of delivery room resuscitation
Time frame: on admission
to investigate risk factors of delivery room resuscitation
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 13 Oct 2023.
- Derived from this study: PubMed 38897621Li S, Feng Q, Huang X, Tian X, Zhou Y, Ji Y, Zhai S, Guo W, Zheng R, Wang H. Association of different doses of antenatal corticosteroids exposure with early major outcomes and early weight loss percentage in extremely preterm infants or extremely low birthweight infants: a multicentre cohort study. BMJ Paediatr Open. 2024 Jun 18;8(1):e002506. doi: 10.1136/bmjpo-2024-002506.
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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.
Qi Feng study chair
Peking University First Hospital
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 Death, run by Peking 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 3 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: finished, as of the sponsor's last update on 13 Oct 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 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?
incidences (time frame: at 36 weeks' corrected age (CA) or at discharge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06082414, which also lists 1 linked publication.
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 13 Oct 2023.