Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516846-20-00

Enrollment

228

Registered

2024-09-03

Start date

2021-09-26

Completion date

Unknown

Last updated

2025-10-29

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

Conditions

Patent Ductus Arteriosus

Brief summary

The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.

Detailed description

The secondary endpoint of CLD will be assessed at 36 weeks CGA. All other secondary endpoints will be assessed at discharge home, apart from developmental outcome at 2 years of corrected gestational age which will be assessed by Bayley’s assessment as phase 3 of ETAPA trial (and is not part of this protocol)

Interventions

DRUGSodium Chloride 0.9% w/v Intravenous Infusion BP Solution for Infusion

DRUGParacetamol 10mg/ml solution for infusion

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The primary endpoint of PIVH ≥grade II, NEC ≥grade IIa (Bell's staging), and death will be assessed at discharge.	—

Secondary

Measure	Time frame
The secondary endpoint of CLD will be assessed at 36 weeks CGA. All other secondary endpoints will be assessed at discharge home, apart from developmental outcome at 2 years of corrected gestational age which will be assessed by Bayley’s assessment as phase 3 of ETAPA trial (and is not part of this protocol)	—

Countries

Czechia, Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026