Cerebral Oxygenation and Autoregulation in Preterm Infants

NCT02147769 | Completed Results

• 1 other identifier: 23894
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 7

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.

Conditions

Intraventricular Hemorrhage of Prematurity; Complications of Prematurity

Keywords

cerebral autoregulation; preterm; near-infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (1)

Preterm infants monitored with NIRS

All infants enrolled in the study will be monitored with cerebral near-infrared spectroscopy (NIRS monitoring) to measure cerebral oxygenation levels in the first 96 hours of life. Mean arterial blood pressure will simultaneously be monitored.

Device: NIRS monitoring

Interventions

NIRS monitoring DEVICE

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

Preterm infants monitored with NIRS

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Medtronic - MITG: collaborator

Study Sites (7)

University of Alabama

Birmingham, Alabama, 35249, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Santa Clara Valley Medical Center

San Jose, California, 95128, United States

Location

Yale-New Haven Children's Hospital

New Haven, Connecticut, 06520, United States

Location

St. John's Children's Hospital

Springfield, Illinois, 62702, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (6)

• 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.

  PMID: 23973384 BACKGROUND

• 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.

  PMID: 23140883 BACKGROUND

• 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.

  PMID: 17515873 BACKGROUND

• 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.

  PMID: 22905222 BACKGROUND

• 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.

  PMID: 21364491 BACKGROUND

• 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.

  PMID: 18250118 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Results Point of Contact

• Title: Valerie Chock, MD
• Organization: Stanford University

vchock@stanford.edu

650-723-5711

Study Officials

• Valerie Chock, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Krisa Van Meurs, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: April 7, 2020
• Results First Posted: April 7, 2020

Record last verified: 2020-04

Locations

US (7)