NCT00166101|Completed
NIRS in Neonatal Cardiac Surgery
Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion
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Near Infrared Spectroscopy Monitoring of Cerebral Oxygen Saturation in Neonatal Cardiac Surgery - Comparison With Common Methods of Estimating Adequate Systemic Perfusion
Sponsor study identifier
observational
25
1 country
1
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Due to the small size of infants and the use of bypass machines, physicians have difficulty assessing whether the infant's brain and body is getting enough oxygen during heart surgery. This study compares continuous monitoring via the NIRS (Near Infrared Spectroscopy) to the traditional methods of determining oxygen saturation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
September 12, 2005
Actual (reported)September 14, 2005
Actual (reported)August 2008
Actual (reported)August 2008
Actual (reported)Neonates with Hypoplastic Left Heart Syndrome undergoing stage 1 palliation with the Norwood procedure.
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Adcock LM, Wafelman LS, Hegemier S, Moise AA, Speer ME, Contant CF, Goddard-Finegold J. Neonatal intensive care applications of near-infrared spectroscopy. Clin Perinatol. 1999 Dec;26(4):893-903, ix.
Madsen PL, Secher NH. Near-infrared oximetry of the brain. Prog Neurobiol. 1999 Aug;58(6):541-60. doi: 10.1016/s0301-0082(98)00093-8.
Kurth CD, Steven JM, Nicolson SC. Cerebral oxygenation during pediatric cardiac surgery using deep hypothermic circulatory arrest. Anesthesiology. 1995 Jan;82(1):74-82. doi: 10.1097/00000542-199501000-00011.
Steven Tosone, MD
Emory University
25 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
August 2002
Date type not reportedThis date has not been verified as actual or estimated.
Study of Sutures Versus Staples for Skin Closure After Surgical Procedures of Hip
Contact the study team to confirm eligibility.
Nollert G, Shin'oka T, Nagashima M, Shum-Tim D. Cerebral oxygenation during cardiopulmonary bypass in children. J Thorac Cardiovasc Surg. 1997 Nov;114(5):871-3. doi: 10.1016/S0022-5223(97)70105-3. No abstract available.
Daubeney PE, Pilkington SN, Janke E, Charlton GA, Smith DC, Webber SA. Cerebral oxygenation measured by near-infrared spectroscopy: comparison with jugular bulb oximetry. Ann Thorac Surg. 1996 Mar;61(3):930-4. doi: 10.1016/0003-4975(95)01186-2.
Wardle SP, Yoxall CW, Weindling AM. Determinants of cerebral fractional oxygen extraction using near infrared spectroscopy in preterm neonates. J Cereb Blood Flow Metab. 2000 Feb;20(2):272-9. doi: 10.1097/00004647-200002000-00008.
Daubeney PE, Smith DC, Pilkington SN, Lamb RK, Monro JL, Tsang VT, Livesey SA, Webber SA. Cerebral oxygenation during paediatric cardiac surgery: identification of vulnerable periods using near infrared spectroscopy. Eur J Cardiothorac Surg. 1998 Apr;13(4):370-7. doi: 10.1016/s1010-7940(98)00024-4.
Kurth CD, Steven JM, Nicolson SC, Chance B, Delivoria-Papadopoulos M. Kinetics of cerebral deoxygenation during deep hypothermic circulatory arrest in neonates. Anesthesiology. 1992 Oct;77(4):656-61. doi: 10.1097/00000542-199210000-00007.
Watzman HM, Kurth CD, Montenegro LM, Rome J, Steven JM, Nicolson SC. Arterial and venous contributions to near-infrared cerebral oximetry. Anesthesiology. 2000 Oct;93(4):947-53. doi: 10.1097/00000542-200010000-00012.
du Plessis AJ, Newburger J, Jonas RA, Hickey P, Naruse H, Tsuji M, Walsh A, Walter G, Wypij D, Volpe JJ. Cerebral oxygen supply and utilization during infant cardiac surgery. Ann Neurol. 1995 Apr;37(4):488-97. doi: 10.1002/ana.410370411.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
November 14, 2012
Record last verified: 2012-11
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