Research study for early treatment of Patent Ductus Arteriosus, placebo against paracetamol in extremely low birth weight infants (ETAPA)

Phase 1

• Conditions: Patent Ductus Arteriosus; MedDRA version: 20.0Level: PTClassification code 10034130Term: Patent ductus arteriosusSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2020-004245-37-CZ
• Lead Sponsor: niversity College Dublin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-10
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

- They are inborn or transferred to a participating centre after birth and have a birth weight of <1000g established by weight assessment on admission to NICU.
- The treating doctors plan to offer them intensive care.
- Large PDA is present on fnECHO, defined as PDA with diameter greater than 1.5mm with non-restrictive flow (defined as diastolic flow less than 50% of systolic flow), determined by targeted fnECHO between 6 and 12 hours of age.

Are the trial subjects under 18? yes
Number of subjects for this age range: 218
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/PFO), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18.
- The treating clinician does not intend to offer the infant intensive care.
- Bidirectional shunt of PDA on ECHO (defined as shunt exceeding 30% of the right to left proportion of the shunting).
- Grade II – IV IVH on point of care CRUSS on screening (between six to twelve hours of age).
- PH prior to study commencement.
- Severe PPHN.
- History or examination suggestive of liver failure prior to study commencement.
- Written informed consent has not been obtained before the infant is 12 hours of age, or the infant’s parent(s)/guardian(s) withdraw consent prior to commencement of the trial processes or assessments.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified