Haemoglobin transfusion thresholds and primary outcome for ETTNO and TOP trials
Study | ETTNO trial24 | TOP trial25 | ||||||
Transfusion threshold group | Higher | Lower | Higher | Lower | ||||
Severity stratum | Critical | Non-critical | Critical | Non-critical | Respiratory support | No respiratory support | Respiratory support | No respiratory support |
Haemoglobin threshold,* g/dL | ||||||||
Week 1 | 13.7 | 11.7 | 11.3 | 9.3 | 13.0 | 12.0 | 11.0 | 10.0 |
Weeks 2–3 (ETTNO) or 2 (TOP) | 12.3 | 10.3 | 10.0 | 8.0 | 12.5 | 11.0 | 10.0 | 8.5 |
Week >3 (ETTNO) or ≥3 (TOP) | 11.3 | 9.3 | 9.0 | 7.0 | 11.0 | 10.0 | 8.5 | 7.0 |
Primary outcome | Neurodevelopmental impairment† at 2 years’ corrected age or death before assessment | Neurodevelopmental impairment‡ at 2 years’ corrected age or death before assessment |
*Thresholds varied with postnatal age and/or degree of illness24 or level of respiratory support25; haematocrit thresholds24 were converted to haemoglobin levels by dividing by 3.
†Neurodevelopmental impairment defined as any of the following: (1) cognitive deficit, defined as Bayley-II Mental Developmental Index (MDI) score <85, Bayley-II cognitive raw score below the lower margin of the MDI, inability to be tested because of severe impairment, another cognitive test score of >1 SD below the mean or assessment by the child’s paediatrician of cognitive deficit; (2) cerebral palsy, defined according to the Surveillance of Cerebral Palsy in Europe network; or (3) severe visual or hearing impairment, defined as best-corrected visual acuity of <6/60 and/or need for hearing aid or cochlear implant.
‡Neurodevelopmental impairment defined as any of the following: (1) cognitive delay, defined as Bayley-III composite cognitive score <85; (2) moderate or severe cerebral palsy, defined as Level II or higher on the Gross Motor Function Classification System26; (3) severe vision loss, defined as corrected visual acuity in the better eye of <20/200; or (4) severe hearing impairment, defined as bilateral hearing loss requiring hearing aids or cochlear implants.