SafeBoosC-IIIv

About this trial

Last updated 2 years ago

Study ID

SafeBoosC-IIIv

Status

Not yet recruiting

Type

Interventional

Phase

Phase 3

Placebo

Accepting

Up to 28 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Started a year ago

The objective of the SafeBoosC-IIIv trial is to evaluate cerebral oximetry added to usual care versus usual care in mechanically ventilated newborns. The hypothesis is that the intervention will decrease a composite outcome of death or moderate to severe neurodevelopmental disability and/or increase the mean PARCA-R non-verbal cognitive score at two years of corrected age.

Inclusion Criteria

- Gestational age more than 28+0 weeks

- Postnatal age less than 28 days

- Expected to receive mechanical ventilation for at least 24 hours, as judged by the physician intending to randomise

- Equipoise as regards the need for cerebral oximetry

- Parental informed consent unless the centre has chosen to use 'opt-out' or deferred consent as consent method.

Exclusion Criteria

- No signed parental informed consent (if prior consent is used), or lack of a record that the clinician has explained the trial to the parents and the parents agreed (if 'opt-out' is used,)

- Suspicion of or confirmed brain injury or disorder (e.g. perinatal asphyxia, cerebral haemorrhage, cerebral malformation, genetic or metabolic disease)

- A cerebral oximeter is not available

- Newborns with congenital heart malformations who is likely to need surgery.

Safeguarding the Brain of Our Smallest Children-IIIv (SafeBoosC-IIIv)