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

NCT06950164 — Active not recruiting, 200 participants, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

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Registry	NCT06950164, acronym PDA
Status	Active not recruiting
Study type	Observational
Enrollment	200 (Estimated)
Sponsor	Daping Hospital and the Research Institute of Surgery of the Third Military Medical University (Other); collaborators: Chongqing Medical Center for Women and Children
Conditions	Preterm, Ductus Arteriosus
Interventions	observation group, control group (Other)
Dates	start 2025-04-01, primary completion 2026-04-30 (estimated), completion 2026-04-30 (estimated), first posted 2025-04-30, last updated 2025-04-30
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
observation group		Other: observation group	in the group, no intervention was given, and the preterm infants were diagnosed with respiratory distress syndrome(RDS)
control group		Other: control group	in the group, no intervention was given, but the preterm infants were diagnosed without respiratory distress syndrome(RDS)

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

+Outcome measures

Primary outcomes

the incidence of patent ductus arteriosus(PDA) [three months after birth]: when did the ductus arteriosus close
dynamic changes of ductus arteriosus in diameter, velocity and direction of blood flow [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

Secondary outcomes

the incidence of bronchopulmonary dysplasia [36 weeks' gestational age]: whether or not bronchopulmonary dysplasia was assessed in 36 weeks' gestational age
the incidence of intraventricular hemorrhage(IVH) [36 weeks' gestational age]: whether or not intraventricular hemorrhage(IVH) was assessed
necrotizing enterocolotis(NEC) [36 weeks' gestational age]: whether or not NEC was assessed

+Eligibility

Sex: All, ages: 1 Minute to 1 Hour

Inclusion Criteria:

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

Exclusion Criteria:

* congenital abnormalities
* parents' refusal

+Locations (1)

Facility	City	Country	Status
Women and Children's hospital of Chonqing Medical University	Chongqing, Chongqing Municipality	China