None listed
Conditions
Brief summary
Preterm babies can develop brain injury which leads to long-term developmental problems. Most brain injuries occur within the first 5 days of life and protection of the brain during this critical period is essential. Fluctuating brain oxygen levels is one reason for brain injury to develop, which can also cause bleeding in the brain. Keeping brain oxygen levels in a specific range may be protective. The purpose of the study is to investigate in preterm babies, whether it is possible to keep brain oxygen levels in a specific range for the first 5 days by NIRS monitoring and following a dedicated clinical treatment guideline. We hypothesise that a combination of brain oxygen monitoring and offering treatment when brain oxygen levels are outside the range may reduce fluctuations in brain oxygen levels and reduce brain injury. Babies in this study will have either (a) the usual treatment (given to all babies), or (b) they will be in the group where the focus is on keeping brain oxygen levels in a specific range for the first 5 days of life using NIRS monitoring.
Interventions
NIRTURE trial will be a single-blinded randomised controlled trial with two parallel groups that are stratified for site and gestational age (less than 26 weeks and greater than or equal to 26+0 – 28+6 weeks gestation). Enrolment will occur after birth of the baby. After enrolment, infants will be randomised to either control group or intervention group. For all enrolled babies, monitoring of cerebral oxygenation will be commenced by placement of a non-adhesive probe on the fronto-parietal regio
NIRTURE trial will be a single-blinded randomised controlled trial with two parallel groups that are stratified for site and gestational age (less than 26 weeks and greater than or equal to 26+0 – 28+6 weeks gestation). Enrolment will occur after birth of the baby. After enrolment, infants will be randomised to either control group or intervention group. For all enrolled babies, monitoring of cerebral oxygenation will be commenced by placement of a non-adhesive probe on the fronto-parietal region of the forehead within 6 hours of birth and monitoring will be continued for 5 days. For the intervention group, the cerebral oxygenation (crSO2) reading is visible and the baby will be treated according to a dedicated clinical guideline when the cerebral oxygenation is outside the range of 65% to 90%. The probe will be moved every 4 hours. The intervention will be delivered by the bedside medical and nursing team using a treatment algorithm. Research team will review the adherence to the protocol with bedside forms when the crSo2 is is less than 65% or more than 90%. The dedicated clinical guideline was designed based on the evidence that affected regional oxygen saturation. Cerebral oxygen monitoring and intervention will cease after 5 days of age.
Sponsors
Western Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 6 Hours
Healthy volunteers
No
Inclusion criteria
• Preterm infants (singleton or twin births) less than 29 weeks gestation who are either inborn (born at the local study site hospital) or outborn (born outside the local study site hospital) and less than 6 hours of age when admitted to the study site NICU.
Exclusion criteria
• Infants with an antenatal or postnatal diagnosis of major congenital anomaly requiring major surgery or a genetic disorder associated with neurological impairment. • Multiple births beyond twins are excluded for practical reasons (sites may not have additional NIRS monitors and the rates of multiple births beyond twins in Australia and New Zealand is very low < 2%).
Outcome results
None listed