The effect of targeting brain oxygenation on neuro-developmental outcomes in extremely pre-term infants: A pilot blinded randomised controlled trial

• Register: ANZCTR
• Last refreshed on: 28 June 2021
• Main ID: ACTRN12621000778886
• Date of registration: 22/06/2021
• Prospective Registration: Yes
• Primary sponsor: Western Sydney Local Health District
• Public title: The effect of targeting brain oxygenation on neuro-developmental outcomes in extremely pre-term infants: A pilot blinded randomised controlled trial
• Scientific title: Does Near Infra-Red spectroscopy Targeted Use Reduce adverse outcomes in Extremely preterm infants? (NIRTURE trial)
• Date of first enrolment: 26/07/2021
• Target sample size: 100
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12621000778886.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
• Phase: Not Applicable

Countries of recruitment

Australia, New Zealand, United States of America

Contacts

• Name: Dr Himanshu Popat

• Name: Dr Traci-Anne Goyen

Key inclusion & exclusion criteria

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%).


Age minimum: Hours
Age maximum: 6 Hours
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Premature birth;brain injury;
Premature birth
brain injury

Reproductive Health and Childbirth - Complications of newborn

Intervention(s)

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.

Primary Outcome(s)

cerebral oxygen saturation assessed using a near-infrared spectroscopy probe placed on the fronto-parietal region of the forehead[Monitored continuously from within 6 hours of birth to 5 days post-birth]

Secondary Outcome(s)

chronic lung disease[Prior to home discharge by accessing patient medical records]

• Brain injury based on cerebral imaging (head ultrasound and / MRI brain),
[Prior to home discharge]

• Measurement of heart rate (assessed by oximeter)[Monitored continuously from within 6 hours of birth to 5 days post-birth]

• Motor performance assessment (General movements assessment)[during NICU stay and at 4 months corrected age follow up.]

• Neuro-developmental outcomes using Wechsler Preschool and Primary Scale of Intelligence tool (verbal comprehension, visual spatial, fluid reasoning, working memory, processing speed, Full scale IQ)[5 years post intervention]

• Neuro-developmental outcomes using Bayley Scales of Infant Development (BSID) IVth Edition tool (cognition scaled score, cognition standard score, receptive language scaled score, expressive language scaled score, language standard score, fine motor scaled score, gross motor scaled score, motor standard score)[2 years post-intervention completion.]

• Newborn mortality rates assessed by accessing patient medical records


[prior to home discharge.]

Monitoring of peripheral saturation (assessed by oximeter)[Monitored continuously from within 6 hours of birth to 5 days post-birth]

Necrotising enterocolitis[Prior to home discharge by accessing patient medical records]

Retinopathy of prematurity[Prior to home discharge by accessing patient medical records]

Secondary ID(s)

None

Source(s) of Monetary Support

Research Foundation, Cerebral Palsy Alliance

Ethics review

Status: Approved
Approval date: 08/12/2020
Contact:

The Sydney Children's Ethics Committee