Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05896306
Status:
RECRUITING
Last Update Posted:
2023-07-03
First Post:
2023-05-31
Brief Title:
Cerebral Monitoring Using Pulsatile Near Infrared Spectroscopy in Neonates
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
Assessment of Cerebral Monitoring Using the Pulsatile Near Infrared Spectroscopy in Neonates Immediately After Birth - a Prospective Observational Pilot Study
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
pNIRS
Brief Summary:
The transition from fetus to newborn is a complex physiological process Monitoring this process to detect potential disruptions is critical but remains a challenge Initial evaluation of neonates is usually based on visual inspection palpation andor auscultation and response to stimuli To objectify the condition of the newborn during this vulnerable transitional period Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score which is widely used around the world However there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score To objectively assess the condition of the newborn the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography ECG and pulse oximetry in the delivery room in addition to clinical evaluation These monitoring methods allow non-invasive continuous monitoring of SpO2 Oxygen saturation as well as heart rate HR but do not provide information about potentially compromised cardiovascular status resulting in severely restricted oxygen transport to tissues
Cerebral Oxygenation
The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation period The recommended routine monitoring during the neonatal transition is SpO2 and heart rate Unfortunately these parameters do not provide any information about cerebral blood flow or oxygen supply or brain activity About 30 of premature babies develop cerebral hemorrhage in the first 3 days after birth This can lead to the development of hydrocephalus poor neurological outcome and even death For the above reasons there is increasing interest in additional brain monitoring Our research group has already shown in various studies that additional cerebral monitoring using near-infrared spectroscopy NIRS is possible in newborns immediately after birth and may be beneficial during this vulnerable phase of life Furthermore this add-on monitoring could inform interventions to optimize brain oxygenation potentially affecting survival with improved short- and long-term neurological outcomes
Background
The transition from fetus to newborn is a complex physiological process Monitoring this process to detect potential disruptions is critical but remains a challenge Initial evaluation of neonates is usually based on visual inspection palpation andor auscultation and response to stimuli To objectify the condition of the newborn during this vulnerable transitional period Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score which is widely used around the world However there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score To objectively assess the condition of the newborn the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography ECG and pulse oximetry in the delivery room in addition to clinical evaluation These monitoring methods allow non-invasive continuous monitoring of SpO2 as well as HR but do not provide information about potentially compromised cardiovascular status resulting in severely restricted oxygen transport to tissues
Pulsatile mode of NIRS Recently Hamamatsu developed new software and implemented it as a pulsatile mode in one of their near-infrared spectroscopy NIRS instruments the NIRO 200 NX In contrast to the conventional NIRS technique which measures tissue saturation closer to venous oxygen saturation than arterial oxygen saturation the pulsatile NIRS technique uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate cPR and cerebral arterial oxygen saturation SnO2 in small vessels
Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously monitor blood flow to the brain during resuscitation This can be particularly beneficial for critically ill newborns and premature babies
To date no data have been published in neonates using the pulsatile NIRS technique
Cerebral Oxygenation
The brain is one of the most vulnerable organs to hypoxia during the postnatal adaptation period The recommended routine monitoring during the neonatal transition is SpO2 and heart rate Unfortunately these parameters do not provide any information about cerebral blood flow or oxygen supply or brain activity About 30 of premature babies develop cerebral hemorrhage in the first 3 days after birth This can lead to the development of hydrocephalus poor neurological outcome and even death For the above reasons there is increasing interest in additional brain monitoring Our research group has already shown in various studies that additional cerebral monitoring using near-infrared spectroscopy NIRS is possible in newborns immediately after birth and may be beneficial during this vulnerable phase of life Furthermore this add-on monitoring could inform interventions to optimize brain oxygenation potentially affecting survival with improved short- and long-term neurological outcomes
Background
The transition from fetus to newborn is a complex physiological process Monitoring this process to detect potential disruptions is critical but remains a challenge Initial evaluation of neonates is usually based on visual inspection palpation andor auscultation and response to stimuli To objectify the condition of the newborn during this vulnerable transitional period Virginia Apgar developed a clinical assessment-based scoring system called the Apgar Score which is widely used around the world However there is significant inter-observer and intra-observer variability in clinical assessments using the Apgar score To objectively assess the condition of the newborn the latest guidelines for postnatal adaptation and resuscitation recommend the use of electrocardiography ECG and pulse oximetry in the delivery room in addition to clinical evaluation These monitoring methods allow non-invasive continuous monitoring of SpO2 as well as HR but do not provide information about potentially compromised cardiovascular status resulting in severely restricted oxygen transport to tissues
Pulsatile mode of NIRS Recently Hamamatsu developed new software and implemented it as a pulsatile mode in one of their near-infrared spectroscopy NIRS instruments the NIRO 200 NX In contrast to the conventional NIRS technique which measures tissue saturation closer to venous oxygen saturation than arterial oxygen saturation the pulsatile NIRS technique uses a higher measurement rate of 20 Hertz and can therefore measure cerebral pulse rate cPR and cerebral arterial oxygen saturation SnO2 in small vessels
Using the non-invasive pulsatile NIRS technique could be a viable new method to continuously monitor blood flow to the brain during resuscitation This can be particularly beneficial for critically ill newborns and premature babies
To date no data have been published in neonates using the pulsatile NIRS technique
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None