Health Condition 1: J156- Pneumonia due to other Gram-negative bacteria
Conditions
Interventions
Intervention1: cerebral oximetry monitoring: If cerebral oximeter shows values below a fixed threshold, remedial actions will be taking according to a set guideline.
Monitoring will be done for as lon
Sponsors
Copenhagen trial unit
Eligibility
Inclusion criteria
Inclusion criteria: Gestational age more than or equal to 28+0 Postnatal age less than 28 days Expected to receive invasive mechanical ventilation for at least 24 hours Informed written consent from either parent or guardian
Exclusion criteria
Exclusion criteria: Suspicion of or confirmed brain injury or disorder (e.g. perinatal asphyxia, cerebral haemorrhage, cerebral malformation, genetic or metabolic disease) Suspicion or diagnosis of congenital heart malformations who is likely to need surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of hospital free days within 90 days of randomizationTimepoint: number of hospital free days within 90 days of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Death from any cause Bronchopulmonary dysplasia (BPD) Any brain injury diagnosed by imaging Seizures treated with antiepileptic medicine Haemodynamic insufficiency that needs cardiovascular support Spontaneous bowel perforation or necrotising enterocolitis (NEC) Bells grade 2 or more Nosocomial infection AKI & renal replacement long term outcome of neurodevelopment measured by the Parent Report of Children’s Abilities-Revised (PARCA-R) questionnaire at 2 years of corrected age. Timepoint: at discharge & at 2 years | — |
Countries
India
Contacts
Public ContactSaudamini Nesargi
St. Johns Medical College Hospital
Outcome results
None listed