Clinical trial NCT02605733: The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Official title: The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Manifestations
Premature Birth
Hypoxia-Ischemia, Brain
Keywords: Premature infant
Amplitude integrated EEG
Near-infrared spectroscopy
Lead sponsor: Sharp HealthCare
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2015-11-16
Enrollment: 130
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Premature infants delivered at 23 to 31 +6 weeks gestational age at Sharp MBHWN.

Brief summary: The purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks GA) during birth transition and through the first 72 hours of life.

Detailed description: The investigators will measure components of brain function using two sophisticated, non-invasive technologies. First, amplitude integrated electroencephalography (EEG), a "simplified" EEG with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. Second, near-infrared spectroscopy (NIRS) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. Both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.

Eligibility criteria: Inclusion Criteria:

* 23 to 31+6 weeks gestational age at birth

Exclusion Criteria:

* Known congenital anomalies
* Parents refuse consent
* Neonatologist declined due to subject instability

Primary outcomes:
measure: EEG
timeFrame: Birth to 72 hours of life
measure: NIRS
timeFrame: Birth to 72 hours of life
Secondary outcomes:
measure: Apgar scores
timeFrame: 1, 5 and 10 minutes of life if applicable
measure: Cord gases
timeFrame: Upon delivery
measure: Resuscitation intervention
timeFrame: From birth to 10 minutes of life
measure: Maximum FiO2
timeFrame: From birth to 10 minutes of life
measure: Maximum peak inspiratory pressure
timeFrame: From birth to 10 minutes of life
measure: Heart rate
timeFrame: Birth to 72 hours of life
measure: Heart rate by EKG during resuscitation (substudy)
timeFrame: Birth
measure: Cardiac output
timeFrame: From neonatal intensive care unit (NICU) admission through 72 hours of life
measure: Mean arterial blood pressure
timeFrame: From NICU admission through 72 hours of life
measure: Use of cardiac inotropes
timeFrame: From birth through discharge to home, up to 9 months of age
measure: Head Ultrasound
timeFrame: Within 24 hours of life and at approximately 72 hours of life
measure: MRI
timeFrame: From birth through discharge to home, up to 9 months of age
measure: Neurodevelopmental impairment at 2 year follow up
timeFrame: 18 to 30 months corrected gestational age
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Mary Birch Hospital for Women and Newborns
state: California
Study officials:
affiliation: Sharp HealthCare
name: Anup Katheria, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peng S, Boudes E, Tan X, Saint-Martin C, Shevell M, Wintermark P. Does near-infrared spectroscopy identify asphyxiated newborns at risk of developing brain injury during hypothermia treatment? Am J Perinatol. 2015 May;32(6):555-64. doi: 10.1055/s-0034-1396692. Epub 2015 Jan 16.
citation: Ancora G, Maranella E, Locatelli C, Pierantoni L, Faldella G. Changes in cerebral hemodynamics and amplitude integrated EEG in an asphyxiated newborn during and after cool cap treatment. Brain Dev. 2009 Jun;31(6):442-4. doi: 10.1016/j.braindev.2008.06.003. Epub 2008 Jul 22.
citation: Ancora G, Maranella E, Grandi S, Sbravati F, Coccolini E, Savini S, Faldella G. Early predictors of short term neurodevelopmental outcome in asphyxiated cooled infants. A combined brain amplitude integrated electroencephalography and near infrared spectroscopy study. Brain Dev. 2013 Jan;35(1):26-31. doi: 10.1016/j.braindev.2011.09.008. Epub 2011 Nov 13.
citation: Gucuyener K, Beken S, Ergenekon E, Soysal S, Hirfanoglu I, Turan O, Unal S, Altuntas N, Kazanci E, Kulali F, Koc E, Turkyilmaz C, Onal E, Atalay Y. Use of amplitude-integrated electroencephalography (aEEG) and near infrared spectroscopy findings in neonates with asphyxia during selective head cooling. Brain Dev. 2012 Apr;34(4):280-6. doi: 10.1016/j.braindev.2011.06.005. Epub 2011 Jul 7.
citation: Toet MC, Lemmers PM. Brain monitoring in neonates. Early Hum Dev. 2009 Feb;85(2):77-84. doi: 10.1016/j.earlhumdev.2008.11.007. Epub 2009 Jan 17.
citation: Tao JD, Mathur AM. Using amplitude-integrated EEG in neonatal intensive care. J Perinatol. 2010 Oct;30 Suppl:S73-81. doi: 10.1038/jp.2010.93.
citation: Fuchs H, Lindner W, Buschko A, Almazam M, Hummler HD, Schmid MB. Brain oxygenation monitoring during neonatal resuscitation of very low birth weight infants. J Perinatol. 2012 May;32(5):356-62. doi: 10.1038/jp.2011.110. Epub 2011 Aug 18.
citation: Katheria AC, Leone TA, Woelkers D, Garey DM, Rich W, Finer NN. The effects of umbilical cord milking on hemodynamics and neonatal outcomes in premature neonates. J Pediatr. 2014 May;164(5):1045-1050.e1. doi: 10.1016/j.jpeds.2014.01.024. Epub 2014 Feb 20.
citation: Katheria A, Blank D, Rich W, Finer N. Umbilical cord milking improves transition in premature infants at birth. PLoS One. 2014 Apr 7;9(4):e94085. doi: 10.1371/journal.pone.0094085. eCollection 2014.
citation: Noori S, McCoy M, Anderson MP, Ramji F, Seri I. Changes in cardiac function and cerebral blood flow in relation to peri/intraventricular hemorrhage in extremely preterm infants. J Pediatr. 2014 Feb;164(2):264-70.e1-3. doi: 10.1016/j.jpeds.2013.09.045. Epub 2013 Oct 30.
citation: Zhang Y, Chan GS, Tracy MB, Lee QY, Hinder M, Savkin AV, Lovell NH. Cerebral near-infrared spectroscopy analysis in preterm infants with intraventricular hemorrhage. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:1937-40. doi: 10.1109/IEMBS.2011.6090547.
citation: Song J, Zhu C, Xu F, Guo J, Zhang Y. Predictive value of early amplitude-integrated electroencephalography for later diagnosed cerebral white matter damage in preterm infants. Neuropediatrics. 2014 Oct;45(5):314-20. doi: 10.1055/s-0034-1382823. Epub 2014 Jul 8.
citation: Benders MJ, Palmu K, Menache C, Borradori-Tolsa C, Lazeyras F, Sizonenko S, Dubois J, Vanhatalo S, Huppi PS. Early Brain Activity Relates to Subsequent Brain Growth in Premature Infants. Cereb Cortex. 2015 Sep;25(9):3014-24. doi: 10.1093/cercor/bhu097. Epub 2014 May 27.
citation: Pichler G, Avian A, Binder C, Zotter H, Schmolzer GM, Morris N, Muller W, Urlesberger B. aEEG and NIRS during transition and resuscitation after birth: promising additional tools; an observational study. Resuscitation. 2013 Jul;84(7):974-8. doi: 10.1016/j.resuscitation.2012.12.025. Epub 2013 Jan 8.
citation: Katheria AC, Harbert MJ, Nagaraj SB, Arnell K, Poeltler DM, Brown MK, Rich W, Hassen KO, Finer N. The Neu-Prem Trial: Neuromonitoring of Brains of Infants Born Preterm During Resuscitation-A Prospective Observational Cohort Study. J Pediatr. 2018 Jul;198:209-213.e3. doi: 10.1016/j.jpeds.2018.02.065. Epub 2018 Apr 18.