Cerebral Oxygenation and Autoregulation in Preterm Infants

Intraventricular Hemorrhage of Prematurity Clinical Trial

— Early NIRS  

Official title:

Cerebral Oxygenation and Autoregulation in Preterm Infants: Association With Morbidity and Mortality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147769
• Other study ID #: 23894
• Status: Completed
• Start date: May 2014
• Est. completion date: March 2018

Study information

• Verified date: April 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Hours

Eligibility

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

Related Conditions & MeSH terms

• Complications of Prematurity
• Hemorrhage
• Intraventricular Hemorrhage of Prematurity
• Premature Birth

Intervention

Device:
• NIRS monitoring
All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.

Locations

Country	Name	City	State
United States	University of Alabama	Birmingham	Alabama
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Yale-New Haven Children's Hospital	New Haven	Connecticut
United States	Stanford University	Palo Alto	California
United States	Santa Clara Valley Medical Center	San Jose	California
United States	St. John's Children's Hospital	Springfield	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Medtronic - MITG

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality Before Hospital Discharge	Participants will be followed for the outcome of death prior to hospital discharge.	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.
Primary	Severe Central Nervous System (CNS) Morbidity	Routine cranial ultrasound obtained within the first ten days of life will be utilized to detect grade 3 or 4 intraventricular hemorrhage, periventricular leukomalacia, significant ventriculomegaly, or white matter abnormalities.	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