Skip to content

Near-Infrared spectroscopy for Monitoring brain Oxygenation in Premature infants

Cerebral regional oxygenation and neurological outcomes in premature infants

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000852358
Acronym
NIMO-Prem
Enrollment
60
Registered
2017-06-08
Start date
2017-06-16
Completion date
2019-04-30
Last updated
2017-06-12

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

Conditions

None listed

Brief summary

One in 12 babies in New Zealand are born premature. Premature infants, especially those born less than 30 weeks gestation and/or extremely low birth weight (<1000g), carry a disproportionate burden of mortality and lifelong neurodevelopmental disability when compared to their healthy term­born peers. For healthy brain development ensuring adequate supply of oxygenated blood to the brain is critical; however, what constitutes the 'optimal' brain perfusion and oxygen level in premature infants is currently unknown. In this observational study we will utilise portable and non­invasive equipment and radiological imaging to develop better understanding of the optimal brain perfusion and oxygenation targets to prevent mortality and later neurodevelopmental disability. Of note, NIMO­Prem is the New Zealand component of a two­centre international collaborative study (the other centre being Texas Children's Hospital, USA). This study protocol is only applicable to the local study based in Wellington Regional Hospital, Wellington NZ.

Interventions

Informed parental consent will be obtained in all cases prior to data collection. Once the parental consent is obtained, following data will be collected as part of the study. Continuous physiological measurement during the first 72hrs: 1. Cerebral regional oxygenation (using INVOSTM 5100c/ OXYALERTTM NIRSensor Infant/Neonatal) 2. Arterial blood pressure* 3. End-tidal CO2* 4. Peripheral arterial saturation* * These physiological measurements are part of routine clinical care in this cohort

Informed parental consent will be obtained in all cases prior to data collection. Once the parental consent is obtained, following data will be collected as part of the study. Continuous physiological measurement during the first 72hrs: 1. Cerebral regional oxygenation (using INVOSTM 5100c/ OXYALERTTM NIRSensor Infant/Neonatal) 2. Arterial blood pressure* 3. End-tidal CO2* 4. Peripheral arterial saturation* * These physiological measurements are part of routine clinical care in this cohort of patients. Non-continuous investigations: 1. Urinary biomarkers of hypoxic/ischaemic brain injury (urine will be collected non-invasively) 2. Brain perfusion pressure (Middle Cerebral Artery Blood Flow Velocity) using Doppler ultrasound 3. Cranial ultrasound scan (CUSS)** 4. Cardiac echocardiography** 5. MRI brain at term-equivalent age 6. Bayley Infants Neurodevelopmental Scales** ** These investigations are part of routine clinical care in this cohort of patients. However, additional CUSS may be performed for the purpose of the study. Patient characteristics: The following demographic and clinical information will be gathered as part of the study 1. Maternal demographics 2. Relevant maternal past medical, antenatal and perinatal history 3. Infant’s perinatal and postnatal history

Sponsors

Dr Maria Saito-Benz
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 4 Hours
Healthy volunteers
No

Inclusion criteria

Preterm infants (<30 weeks gestation) with extremely low birth weight (<1000g) who are born in Wellington Regional Hospital

Exclusion criteria

1. Complex congenital abnormalities 2. Known genetic abnormalities 3. Poor skin integrity 4. Significant hydrops fetalis 5. Palliation due to extreme condition at birth

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026