Clinical trial NCT02147769: Cerebral Oxygenation and Autoregulation in Preterm Infants
Official title: Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraventricular Hemorrhage of Prematurity
Complications of Prematurity
Keywords: cerebral autoregulation
preterm
near-infrared spectroscopy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2014-05-28
Enrollment: 111
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All inborn preterm infants with birth weight \<=1250 grams and with an indwelling arterial catheter already in place are eligible for study enrollment if they are \<24 hours old at the time of enrollment. These preterm infants are at risk for impaired cerebral autoregulation and may undergo non-invasive monitoring of cerebral oxygenation using near-infrared spectroscopy (NIRS).

Brief summary: Premature infants are at high risk for variations in blood pressure and oxygenation during the first few days of life. The immaturity of the premature brain may further predispose these infants to death or the development of neurologic problems. The relationship between unstable blood pressure and oxygen levels and brain injury has not been well elucidated.

This study investigates the utility of near-infrared spectroscopy (NIRS), a non-invasive oxygen-measuring device, to identify preterm infants at highest risk for brain injury or death.


Eligibility criteria: Inclusion Criteria:

* inborn
* birth weight \<= 1250 grams
* indwelling arterial catheter in place
* age \<24 hours old

Exclusion Criteria:

* lethal chromosomal abnormality
* major congenital anomaly
* skin integrity insufficient to allow placement of NIRS sensors
* decision to not provide full intensive care

Primary outcomes:
measure: Mortality Before Hospital Discharge
timeFrame: Outcome measure will be assessed at the time of subject's initial discharge from the hospital (on average by 40 weeks postmenstrual age), but at a maximum of 1 year of life.
measure: Severe Central Nervous System (CNS) Morbidity
timeFrame: Outcome measure will be assessed on day 10 of life. Participants will be followed for neuroradiographic evidence of CNS morbidity in the first ten days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Medical Center
state: California
city: New Haven
country: United States
facility: Yale-New Haven Children's Hospital
state: Connecticut
city: Springfield
country: United States
facility: St. John's Children's Hospital
state: Illinois
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Stanford University
name: Valerie Chock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Krisa Van Meurs, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Verhagen EA, Hummel LA, Bos AF, Kooi EM. Near-infrared spectroscopy to detect absence of cerebrovascular autoregulation in preterm infants. Clin Neurophysiol. 2014 Jan;125(1):47-52. doi: 10.1016/j.clinph.2013.07.001. Epub 2013 Aug 22.
citation: Alderliesten T, Lemmers PM, Smarius JJ, van de Vosse RE, Baerts W, van Bel F. Cerebral oxygenation, extraction, and autoregulation in very preterm infants who develop peri-intraventricular hemorrhage. J Pediatr. 2013 Apr;162(4):698-704.e2. doi: 10.1016/j.jpeds.2012.09.038. Epub 2012 Nov 6.
citation: Soul JS, Hammer PE, Tsuji M, Saul JP, Bassan H, Limperopoulos C, Disalvo DN, Moore M, Akins P, Ringer S, Volpe JJ, Trachtenberg F, du Plessis AJ. Fluctuating pressure-passivity is common in the cerebral circulation of sick premature infants. Pediatr Res. 2007 Apr;61(4):467-73. doi: 10.1203/pdr.0b013e31803237f6.
citation: Wong FY, Silas R, Hew S, Samarasinghe T, Walker AM. Cerebral oxygenation is highly sensitive to blood pressure variability in sick preterm infants. PLoS One. 2012;7(8):e43165. doi: 10.1371/journal.pone.0043165. Epub 2012 Aug 14.
citation: Caicedo A, De Smet D, Naulaers G, Ameye L, Vanderhaegen J, Lemmers P, Van Bel F, Van Huffel S. Cerebral tissue oxygenation and regional oxygen saturation can be used to study cerebral autoregulation in prematurely born infants. Pediatr Res. 2011 Jun;69(6):548-53. doi: 10.1203/PDR.0b013e3182176d85.
citation: Wong FY, Leung TS, Austin T, Wilkinson M, Meek JH, Wyatt JS, Walker AM. Impaired autoregulation in preterm infants identified by using spatially resolved spectroscopy. Pediatrics. 2008 Mar;121(3):e604-11. doi: 10.1542/peds.2007-1487. Epub 2008 Feb 4.