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Active Not RecruitingNCT06950164

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
200 (estimated)
Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Academic / Other
Sex
All
Age
1 Minute – 1 Hour
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERobservation groupin the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)
OTHERcontrol groupin the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)

Timeline

Start date
2025-04-01
Primary completion
2026-04-30
Completion
2026-04-30
First posted
2025-04-30
Last updated
2025-04-30

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT06950164. Inclusion in this directory is not an endorsement.