Effects of transfusion thresholds on neurocognitive outcome of extremely low birth weight infants (ETTNO) a blinded randomized controlled multicenter trial - ETTNO

Phase 1

• Conditions: extreme prematurityanemia of prematurityneurodevelopmental impairment; MedDRA version: 12.1Level: LLTClassification code 10002307Term: Anemia of prematurity; MedDRA version: 12.1Level: LLTClassification code 10036615Term: Prematurity

• Registration Number: EUCTR2010-021576-28-DE
• Lead Sponsor: niversitätsklinikum Tuebingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-07
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 920

Inclusion Criteria

birth weight 400-999g
Are the trial subjects under 18? yes
Number of subjects for this age range:
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

Missing written parental consent.
Gestational age > 29 + 6/7 weeks
Major congenital anomalies
Clinical decision to withhold intensive care

Study & Design

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