Skip to content

Early drug targeted therapy for PDA in very-premature and very-low birth weight infants

Early drug targeted therapy for PDA in very-premature and very-low birth weight infants

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067195
Enrollment
Unknown
Registered
2022-12-29
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

patent ductus arteriosus

Interventions

treatment group:Early targeted therapy with ibuprofen
contral group:5% glucose solution
Observation group:N/A

Sponsors

Chengdu Women‘s and Children’s Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Preterm infants with gestational age < 28 weeks and ultra-low birth weight infants with birth weight < 1000g; ? Informed consent of the legal guardian.

Exclusion criteria

Exclusion criteria: ? Those who died or gave up treatment within 1 day after birth; ? Patients with any of the following conditions: PDA right-to-left shunt time in the whole cardiac cycle ratio of =30% or severe pulmonary hypertension; Patients with severe gastrointestinal bleeding, confirmed or suspected NEC (Bell stage II or above), and hydrocortisone use within 12 hours before enrollment; Platelet count 120umol/L or urine volume < 0.5ml/Kg/h; Severe congenital heart malformations (excluding PDA and patent foramen ovale); Associated with other congenital diseases that may cause abnormal development of the nervous system (e.g., genetic chromosomal disorders, congenital brain abnormalities, etc.); The mother had a history of using ibuprofen in the last 6 months; Those who cannot start the trial within 72 hours for other reasons; Patients who did not use umbilical artery catheterization after birth; ? The legal guardian did not agree to participate in the study.

Design outcomes

Primary

MeasureTime frame
Closure of ductus arteriosus;

Countries

China

Contacts

Public ContactLI Huaying

Chengdu Women‘s and Children’s Central Hospital

leave79@163.com13550269790

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026