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Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold

Preterm Oxygenation of the Cerebrum: Key for Erythrocyte-transfusion Threshold

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22948
Enrollment
194
Registered
2017-02-28
Start date
2018-07-19
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Preterm infants, Anemia, Red blood cell transfusion, Transfusion threshold, Neurodevelopmental outcome

Interventions

The intervention strategy group will not receive an RBC transfusion (15-20 ml/kg leukocyte-reduced erythrocytes) in case of an Hb threshold which is 1.0 mmol/l lower than current guidelines, i.e. at a

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - A gestational age < 32 weeks - Age between 0 and 7 days - Written informed consent by legal representative(s)

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Chromosomal abnormality (e.g. trisomy 13, 18, 21) - Perinatal asphyxia resulting in Apgar score (AS) grade 2 according to Papile, prior to inclusion - Alloimmune hemolytic disease, sickle-cell disease or thalassemia - Any received RBC transfusions prior to inclusion - Inability to understand Dutch by the parents - Parents expressing strong philosophical or religious objections to transfusion

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the neurological outcome at the age of three months post term, based on the motor optimality score (MOS) of the quality of General Movements (GMs).

Secondary

MeasureTime frame
Secondary outcomes will be the incidence of in-hospital mortality and morbidities NEC, BPD, ROP, and deterioration of IVH assessed at 3 months post term age. Urinary I-FABP levels will be measured to determine intestinal cell damage as early marker for NEC. Cerebral regional tissue oxygen saturation and the total amount of RBC transfusions during the study period of 4 weeks will be recorded.

Contacts

Public ContactE.M.W. Kooi

UMCG

e.kooi@umcg.nl050-3614215

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)