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

NCT06950164 | Active Not Recruiting DMC

• 1 other identifier: ductus arteriosus
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Preterm; Ductus Arteriosus

Keywords

preterm; patent ductus arteriosus

Outcome Measures

Primary Outcomes (2)

• the incidence of patent ductus arteriosus(PDA)

  when did the ductus arteriosus close

  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

  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

  36 weeks' gestational age

• the incidence of intraventricular hemorrhage(IVH)

  36 weeks' gestational age

• necrotizing enterocolotis(NEC)

  36 weeks' gestational age

Study Arms (2)

observation group

in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)

Other: observation group

control group

in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)

Other: control group

Interventions

observation group OTHER

in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)

observation group

control group OTHER

in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)

control group

Eligibility Criteria

• Age: 1 Minute - 1 Hour
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• congenital abnormalities
• parents' refusal

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Chongqing Medical Center for Women and Children: collaborator

Study Sites (1)

Women and Children's hospital of Chonqing Medical University

Chongqing, Chongqing Municipality, 400147, China

Location

MeSH Terms

Conditions

Premature Birth; Ductus Arteriosus, Patent

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 30, 2025
• Study Start: April 1, 2025
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after paper published
• Access Criteria: Email to neurochenlong@126.com

Locations

CN (1)