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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021576-28-DE

Enrollment

920

Registered

2011-02-07

Start date

2011-06-21

Completion date

Unknown

Last updated

2023-12-19

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

Conditions

extreme prematurity anemia of prematurity neurodevelopmental impairment MedDRA version: 12.1 Level: LLT Classification code 10002307 Term: Anemia of prematurity MedDRA version: 12.1 Level: LLT Classification code 10036615 Term: Prematurity

Interventions

Pharmaceutical Form: Intravenous infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether ‘liberal’ red blood cell transfusion (RBCT) practices that intend to keep the hematocrit levels = 28% at all time during the initial hospitalization improve or impair long-term outcome (i.e., reduce or increase the incidence of death or major neurodevelopmental impairment evaluated at 24 months corrected age) in extremely low birth weight infants if compared with ‘restrictive’ RBCT guidelines that accept hematocrit levels as low as 21% (according to pre-specified RBCT guidelines).;Secondary Objective: To determine whether RBCT-guidelines have an effect on short-term outcomes such as in-hospital growth and mortality, and the incidences of the major diseases of prematurity (i.e., BPD, ROP, necrotizing enterocolitis (NEC), intestinal perforation, brain injury on cranial ultrasound, and patent ductus arteriosus (PDA) requiring therapy), or long-term outcomes such as growth and mortality until follow-up, the mental and physical developmental index scores, and the incidences of the individual components of the primary composite outcome.;Primary end point(s): The primary outcome measure of this study will be the long-term neurocognitive development measured as the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive delay defined as mental developmental index (MDI) score of the Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment)	—

Measure

Time frame

Main Objective: To determine whether ‘liberal’ red blood cell transfusion (RBCT) practices that intend to keep the hematocrit levels = 28% at all time during the initial hospitalization improve or impair long-term outcome (i.e., reduce or increase the incidence of death or major neurodevelopmental impairment evaluated at 24 months corrected age) in extremely low birth weight infants if compared with ‘restrictive’ RBCT guidelines that accept hematocrit levels as low as 21% (according to pre-specified RBCT guidelines).;Secondary Objective: To determine whether RBCT-guidelines have an effect on short-term outcomes such as in-hospital growth and mortality, and the incidences of the major diseases of prematurity (i.e., BPD, ROP, necrotizing enterocolitis (NEC), intestinal perforation, brain injury on cranial ultrasound, and patent ductus arteriosus (PDA) requiring therapy), or long-term outcomes such as growth and mortality until follow-up, the mental and physical developmental index scores, and the incidences of the individual components of the primary composite outcome.;Primary end point(s): The primary outcome measure of this study will be the long-term neurocognitive development measured as the incidence of death or major neurodevelopmental impairment determined at 24 months of age corrected for prematurity (where major neurodevelopmental impairment is defined as any of the following: cognitive delay defined as mental developmental index (MDI) score of the Bayley Scales of Infant Development (2nd edition) < 85, cerebral palsy, or severe visual or hearing impairment)

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Countries

Germany

Outcome results

None listed

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