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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06950164
Acronym
PDA
Enrollment
200
Registered
2025-04-30
Start date
2025-04-01
Completion date
2026-04-30
Last updated
2025-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ductus Arteriosus, Preterm

Keywords

preterm, patent ductus arteriosus

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.

Interventions

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

OTHERcontrol group

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

Sponsors

Chongqing Medical Center for Women and Children
CollaboratorOTHER
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Minutes to 1 Hours
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* congenital abnormalities * parents' refusal

Design outcomes

Primary

MeasureTime frameDescription
the incidence of patent ductus arteriosus(PDA)three months after birthwhen did the ductus arteriosus close
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flowafter 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 closeddynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow were measured

Secondary

MeasureTime frameDescription
necrotizing enterocolotis(NEC)36 weeks' gestational agewhether or not NEC was assessed
the incidence of bronchopulmonary dysplasia36 weeks' gestational agewhether or not bronchopulmonary dysplasia was assessed in 36 weeks' gestational age
the incidence of intraventricular hemorrhage(IVH)36 weeks' gestational agewhether or not intraventricular hemorrhage(IVH) was assessed

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026