Trial | Year published | Region | Primary Outcome | Death as a part of primary outcome |
---|---|---|---|---|
Neurodevelopmental impairment as a binary outcome | ||||
Benefits of Oxygen Saturation Targeting (BOOST-II UK)22 | Ongoing 2 year outcomes pending | UK | Composite of death or serious neurodisability at age 2 years corrected age (serious neurodisability defined as a Bayley-III language or cognitive score <85 or equivalent; or severe visual loss or severe cerebral palsy or deafness). | Yes |
Total Body Hypothermia (TOBY)23 | 2009 | UK Finland Hungary Israel Sweden | Composite of death or severe neurodisability at 18 months of age (severe neurodisability defined as BSID-II Mental Development Index (MDI) <70, GMFCS Level 3 to 5, or severe visual loss). | Yes |
National Institute of Child Health and Human Development (NICHD) trial on total body hypothermia24 | 2005 | USA | Composite of death or moderate (BSID-II MDI 70 to 84 or GMFCS Level 2 or hearing impairment with no amplification or persisting seizure disorder) or severe (BSID-II MDI<70 or GMFCS Levels 3–5 or blindness or hearing requiring hearing aids) neurodisability at 18–22 months of age. | Yes |
GRIT (Growth Restriction Intervention Trial)25 | 2004 | UK Belgium Czech Republic Germany Greece Hungary Italy Netherlands Poland Portugal Saudi Arabia Slovenia | Composite of death or disability at or after 2 years corrected age (Disability defined as Griffith GQ ≤70 or diagnosis of cerebral palsy or severe visual loss or deafness) | Yes |
INIS (International Neonatal Immunotherapy Study)19 | 2011 | UK Argentina Australia Belgium Denmark Greece Ireland New Zealand Serbia | Composite of death or major disability at 2 years corrected age. (Major disability defined as per criteria set out in the National Perinatal Epidemiology Unit (NPEU) and Oxford Regional Health Authority report1 and includes any major disability in neuromotor function, seizures, auditory function, communication, visual function, cognitive function and other physical disability. Cognitive delay defined as PARCA-R <31)19 | Yes |
INNOVO Trial (Neonatal ventilation with INhaled Nitric Oxide versus Ventilatory support withOut inhaled nitric oxide for severe respiratory failure: a multicentre randomised controlled trial, RCT)26 | 2005 | UK Ireland | Death and disability at 1 year corrected age (Disability defined by set clinical criteria, no psychometric scales used). | Yes |
Trial of umbilical and fetal flow in Europe (TRUFFLE): a multicentre randomised study27 | Ongoing | UK Austria Germany Italy Netherlands | Survival without neurodevelopmental impairment at 2 years corrected age (neurodevelopmental impairment defined as Bayley-III Cognitive composite score ≤70 or severe visual loss or GMFCS level ≥2 or deafness) | Yes |
Neurodevelopmental impairment as a continuous outcome | ||||
Neonatal ECMO Study of Temperature (NEST): A Randomized Controlled Trial7 | 2013 | UK | Bayley-III Cognitive composite score at 2 years corrected age (24–27 months) | No |
A RCT of peer-mentoring for first-time mothers in socially disadvantaged areas (the MOMENTS Study)28 | 2011 | UK | BSID-II MDI and Psychomotor Development Index (PDI) at 1 year | No |
Iodine supplementation study in preterm infants (I2S2)8 | Ongoing | UK | Neurodevelopmental status at 2 years corrected (for prematurity). Neurodevelopmental status is defined by the three main domains of the Bayley-III scales, that is, cognitive score, language composite score and motor composite score. | Yes |