Premature Birth Clinical Trial
Official title:
The Continuous Monitoring of Cerebral Function, Oxygen Perfusion and Consumption in Extremely Premature Newborns
We are attempting to improve the cerebral monitoring of extremely low gestational age (ELGA)
infants, such that in the future, real-time monitoring will be possible, to aid clinicians in
their management of these infants. We wish to establish a new NIRS device, diffuse
correlation spectroscopy (DCS), as a safe, noninvasive and informative bedside tool for
assessing and monitoring brain health in ELGA infants during the first few days of life. It
is hoped that this method will provide detailed information on changes in oxygen consumption
and metabolism, and cerebral perfusion. This technique will have wide applicability, but for
this research study we wish to focus on the effect of blood flow instabilities, intermittent
hypotension and hypoxic episodes, pressure passive CBF periods, and hypoperfusion on the
preterm brain during the first days of life, and their relationship with incidence of
intraventricular hemorrhage (IVH). We aim to recruit 100 premature infants to obtain data to:
1. Test the feasibility of NIRS-DCS to monitor cerebral activity, perfusion and oxygen
consumption in extremely premature infants during the first week of life.
2. To assess if these baseline values are impacted by intermittent hypoxic episodes.
3. To assess if cerebral blood flow disturbances correlate with incidence of
intraventricular hemorrhage.
4. Correlate the NIRS-DCS findings with clinical outcome at hospital discharge.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 72 Hours |
Eligibility |
- Premature infants born at <29 weeks GA and <48 hrs of age. - No contraindication to DCS optical sensor placement on the scalp - No major congenital anomalies, - No Complex cyanotic congenital cardiac disease. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Maria Angela Franceschini | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Test the feasibility of DCS CBF continuous measures in ELGA newborn | Test the feasibility of DCS monitoring of cerebral perfusion in extremely premature infants during the first few days of life. | 5 years | |
Secondary | Correlation with intraventricular hemorrhage | To assess if cerebral blood flow disturbances measured with DCS correlate with incidence of intraventricular hemorrhage. | 5 years | |
Secondary | Correlation with clinical outcome | Correlate the DCS findings with clinical outcome at hospital discharge | 5 years |
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