PretermPDANCT06950164
Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study
An observational study of Preterm and Ductus Arteriosus, run by Daping Hospital and the Research Institute of Surgery of the Third Military Medical University at 1 site in China.
Trial summary
The ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. After birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. Read more about this study
- Who is it for?
- Ages 1 minute to 1 hour
- Conditions the study is for
- Preterm, Ductus Arteriosus
- What is being tested?
- observation group
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 30 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 hour
- All sexes
- No healthy volunteers
- Child
Study population: very preterm infants and extremely preterm infants with respiratory distress syndrome (RDS) and without RDS were included.
Who may be able to join
- less than 32 weeks' gestational age
- admission with 1 hours after birth
Who cannot join
- congenital abnormalities
- parents' refusal
Trial locations and contacts
1 site in 1 country.
China1 site
Women and Children's hospital of Chonqing Medical University
Chongqing, Chongqing Municipality, 400147
About this study
The ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. After birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. The persistent presence of ductus arteriosus leads to significant pressure changes in the systemic and pulmonary circulation, which have adverse effects on extremely/very premature infants. Therefore, persistent patent ductus arteriosus (PDA) is a systemic disease.
Read the detailed description
hemodynamic significant PDA(hsPDA) is a risk factor for intraventricular hemorrhage(IVH), bronchopulmonary dysplasia(BPD), necrotizing enterocolitis(NEC). A meta-analysis from Cochrane shows that compared to conservative treatment, drug therapy for PDA within 3 and 7 days after birth does not promote PDA closure and reduce the incidence of BPD. Therefore, there is currently a tendency not to provide medication intervention. Although ductus arteriosus quickly closes itself after birth in normal term infants, however, the dynamic changes detail of ductus arteriosus in preterm infants are unknown.
- Conditions
- Preterm, Ductus Arteriosus
- Being tested
- observation group, control group
- Keywords
- preterm, patent ductus arteriosus
- Medical subject headings
- Premature Birth, Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation groupOther
in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)
control groupOther
in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)
| Study group | Role | What they receive |
|---|---|---|
| observation group | in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS) Receives: Other: observation group | |
| control group | in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS) Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of patent ductus arteriosus(PDA)
when did the ductus arteriosus close
Measured: three months after birth
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow were measured
Measured: after admission, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 120 hour, 144 hour, 168 hour, 192 hour, 216 hour, 240 hour and 2 weeks or any time of ductus arteriosus closed
Secondary outcomes (3)
the incidence of bronchopulmonary dysplasia
whether or not bronchopulmonary dysplasia was assessed in 36 weeks' gestational age
Measured: 36 weeks' gestational age
the incidence of intraventricular hemorrhage(IVH)
whether or not intraventricular hemorrhage(IVH) was assessed
Measured: 36 weeks' gestational age
necrotizing enterocolotis(NEC)
whether or not NEC was assessed
Measured: 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 posted30 Apr 2025
- Study start1 Apr 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies 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
- 200 participants (estimated)
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
- Chongqing Medical Center for Women and Children
- Responsible party
- Principal investigator, Chen Long,MD, Chongqing Medical Center for Women and Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950164
- Sponsor's protocol ID
- ductus arteriosus
- Acronym
- PDA
- Status last verified
- Mar 2025
- First submitted
- 22 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: after paper published
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study
- ClinicalTrials.gov ID
- NCT06950164
- Acronym / sponsor ID
- PDA / ductus arteriosus
- Conditions
- Preterm, Ductus Arteriosus
- Keywords
- preterm, patent ductus arteriosus
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityUniversity, hospital or other
- Collaborators
- Chongqing Medical Center for Women and Children
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 30 Apr 2025 (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.
The ductus arteriosus quickly closes itself. is an important channel connecting the maternal fetal circulation before birth. After birth, this ductus arteriosus generally no longer has a physical function, so ductus arteriosus quickly closes itself. The persistent presence of ductus arteriosus leads to significant pressure changes in the systemic and pulmonary circulation, which have adverse effects on extremely/very premature infants. Therefore, persistent patent ductus arteriosus (PDA) is a systemic disease.
Detailed description
hemodynamic significant PDA(hsPDA) is a risk factor for intraventricular hemorrhage(IVH), bronchopulmonary dysplasia(BPD), necrotizing enterocolitis(NEC). A meta-analysis from Cochrane shows that compared to conservative treatment, drug therapy for PDA within 3 and 7 days after birth does not promote PDA closure and reduce the incidence of BPD. Therefore, there is currently a tendency not to provide medication intervention. Although ductus arteriosus quickly closes itself after birth in normal term infants, however, the dynamic changes detail of ductus arteriosus in preterm infants are unknown.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| observation group | – | Other: observation groupin the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS) |
| control group | – | Other: control groupin the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS) |
Who may qualify
- Ages
- 1 minute to 1 hour
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- very preterm infants and extremely preterm infants with respiratory distress syndrome (RDS) and without RDS were included.
Key inclusion criteria (2 listed)
- less than 32 weeks' gestational age
- admission with 1 hours after birth
Key exclusion criteria (2 listed)
- congenital abnormalities
- 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 |
|---|---|---|
| observation groupin the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS) | Other | observation group |
| control groupin the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS) | Other | control group |
Primary outcome
the incidence of patent ductus arteriosus(PDA)
Time frame: three months after birth
when did the ductus arteriosus close
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow
Time frame: after admission, 12 hour, 24 hour, 48 hour, 72 hour, 96 hour, 120 hour, 144 hour, 168 hour, 192 hour, 216 hour, 240 hour and 2 weeks or any time of ductus arteriosus closed
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow were measured
3 secondary outcomes
the incidence of bronchopulmonary dysplasia
Time frame: 36 weeks' gestational age
the incidence of intraventricular hemorrhage(IVH)
Time frame: 36 weeks' gestational age
necrotizing enterocolotis(NEC)
Time frame: 36 weeks' gestational age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Yes. after paper published
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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 Preterm and Ductus Arteriosus, 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 2 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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 patent ductus arteriosus(PDA) (time frame: three months after birth). The study lists 2 primary outcomes in all. 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 30 Apr 2025.