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

NCT ID: NCT06950164

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-04-30

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

observation group

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

observation group

Intervention Type: OTHER

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)

control group

Intervention Type: OTHER

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

Interventions

observation group

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

Intervention Type: OTHER

control group

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• congenital abnormalities
• parents' refusal

• Minimum Eligible Age: 1 Minute
• Maximum Eligible Age: 1 Hour
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chongqing Medical Center for Women and Children

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Chen Long,MD

director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women and Children's hospital of Chonqing Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

ductus arteriosus

Identifier Type: -

Identifier Source: org_study_id