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Does the Use of Higher Versus Lower Oxygen Concentration Improve Neurodevelopmental Outcomes at 18-24 Months in Very Low Birthweight Infants: The HiLo-Trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509780-25-00
Acronym
Pro00083931
Enrollment
60
Registered
2024-05-03
Start date
2024-10-09
Completion date
Unknown
Last updated
2024-10-01

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

Conditions

Prematurity

Brief summary

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).

Detailed description

All-cause in-hospital mortality, 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, Bronchopulmonary dysplasia, Severe retinopathy of prematurity (stage 3 or 4 or treated cases)

Interventions

Sponsors

University College Cork
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
All-cause in-hospital mortality, 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, Bronchopulmonary dysplasia, Severe retinopathy of prematurity (stage 3 or 4 or treated cases)

Countries

Ireland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026