OXYGEN PH.EUR. for Prematurity | Very low birth weight

Inclusion criteria

• {"criterion_text":"- Infants with gestational age between 23 to 28 weeks based on best available obstetrical estimate\n- Infants designated to receive full resuscitation, i.e., no parental request or pre-determined decision to forego resuscitation\n- No known major congenital or chromosomal malformation."}

Exclusion criteria

• {"criterion_text":"- Infant born outside of study centers and transported to center after delivery\n- Parents’ refusal to give consent to this study"}

Primary endpoints

• {"endpoint_text":"- The primary outcome is a composite between 18 and 24 months corrected age of all-cause mortality or the presence of a major neurodevelopmental outcome defined as any one of: (i) non-ambulatory cerebral palsy; (ii) severe cognitive delay, (iii) hearing impairment (requiring a hearing aid or cochlear implants), and (iv) visual (cannot fixate/ legally blind, or corrected acuity <6/60 in both eyes).","definition_or_measurement_approach":"Composite measured between 18 and 24 months corrected age; components are defined in-text: non-ambulatory cerebral palsy; severe cognitive delay; hearing impairment requiring hearing aid or cochlear implants; visual impairment as cannot fixate/legally blind or corrected acuity <6/60 in both eyes. All-cause mortality included as part of composite."}

Secondary endpoints

• {"endpoint_text":"- All-cause in-hospital mortality","definition_or_measurement_approach":"All-cause mortality occurring during initial hospitalisation (in-hospital)."}
• {"endpoint_text":"- Severe brain injury, defined as Grade 3 and 4 IVH / intraparenchymal hemorrhage or echodense intraparenchymal lesions, periventricular leukomalacia, porencephalic cysts or ventriculomegaly on cranial ultrasound","definition_or_measurement_approach":"Severe brain injury defined by specified cranial ultrasound findings (Grade 3–4 IVH, intraparenchymal hemorrhage or echodense intraparenchymal lesions, PVL, porencephalic cysts, or ventriculomegaly)."}
• {"endpoint_text":"- Bronchopulmonary dysplasia","definition_or_measurement_approach":"Bronchopulmonary dysplasia as recorded/diagnosed per trial/clinical criteria (definition not further specified in provided text)."}
• {"endpoint_text":"- Severe retinopathy of prematurity (stage 3 or 4 or treated cases)","definition_or_measurement_approach":"Severe ROP defined as stage 3 or 4, or cases requiring treatment."}

Ireland

Latest Decision Or Authorization Date

20-04-2026

Number Of Sites

1

Number Of Participants

65

Primary sponsor

Full Name

University College Cork

Organisation Type

Educational Institution

Country Of Registered Address

Ireland

Third parties

• {"country":"Canada","full_name":"Canadian Institute of Health Research Foundation Grant (CIHR)","duties_or_roles":"Source of monetary support / grant funding","organisation_type":"Funding body"}