Dynamic Changes of Ductus Arteriosus in < 31 Weeks Preterm Infants: an Observational Study (PDA)

April 22, 2025 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400147
        • Women and Children's hospital of Chonqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

very preterm infants and extremely preterm infants with respiratory distress syndrome (RDS) and without RDS were included.

Description

Inclusion Criteria:

  • less than 32 weeks' gestational age
  • admission with 1 hours after birth

Exclusion Criteria:

  • congenital abnormalities
  • parents' refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
observation group
in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)
Other: observation group
in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)
control group
in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)
Other: control group
in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of patent ductus arteriosus(PDA)
Time Frame: three months after birth
when did the ductus arteriosus close
three months after birth
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of bronchopulmonary dysplasia
Time Frame: 36 weeks' gestational age
whether or not bronchopulmonary dysplasia was assessed in 36 weeks' gestational age
36 weeks' gestational age
the incidence of intraventricular hemorrhage(IVH)
Time Frame: 36 weeks' gestational age
whether or not intraventricular hemorrhage(IVH) was assessed
36 weeks' gestational age
necrotizing enterocolotis(NEC)
Time Frame: 36 weeks' gestational age
whether or not NEC was assessed
36 weeks' gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Chongqing Medical Center for Women and Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ductus arteriosus

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

after paper published

IPD Sharing Time Frame

6 months after paper published

IPD Sharing Access Criteria

Email to neurochenlong@126.com

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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