The Neu-Prem Trial: Neuromonitoring of Preterm Newborn Brain During Birth Resuscitation

NCT02605733 | Completed

• 1 other identifier: Neu-Prem
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Manifestations; Premature Birth; Hypoxia-Ischemia, Brain

Keywords

Premature infant; Amplitude integrated EEG; Near-infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

• EEG

  amplitude integrated EEG to measure brain activity

  Birth to 72 hours of life

• NIRS

  Cerebral tissue oxygen saturation (StO2), Near-infrared spectroscopy to measure brain perfusion

  Birth to 72 hours of life

Secondary Outcomes (13)

• Apgar scores

  1, 5 and 10 minutes of life if applicable

• Cord gases

  Upon delivery

• Resuscitation intervention

  From birth to 10 minutes of life

• Maximum FiO2

  From birth to 10 minutes of life

• Maximum peak inspiratory pressure

  From birth to 10 minutes of life

Interventions

EEG DEVICE

amplitude integrated electroencephalography

Also known as: amplitude integrated electroencephalography

NIRS DEVICE

regional tissue oximetry

Also known as: Near-infrared spectroscopy

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants delivered at 23 to 31 +6 weeks gestational age at Sharp MBHWN.

You may qualify if:

• to 31+6 weeks gestational age at birth

You may not qualify if:

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

Sponsors & Collaborators

• Sharp HealthCare: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

Location

Related Publications (15)

• 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.

  PMID: 25594221 BACKGROUND

• 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.

  PMID: 18650042 BACKGROUND

• 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.

  PMID: 22082686 BACKGROUND

• 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.

  PMID: 21741190 BACKGROUND

• 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.

  PMID: 19150756 BACKGROUND

• 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.

  PMID: 20877412 BACKGROUND

• 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.

  PMID: 21852771 BACKGROUND

• 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.

  PMID: 24560179 BACKGROUND

• 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.

  PMID: 24709780 BACKGROUND

• 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.

  PMID: 24183212 BACKGROUND

• 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.

  PMID: 22254711 BACKGROUND

• 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.

  PMID: 25003781 BACKGROUND

• 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.

  PMID: 24867393 BACKGROUND

• 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.

  PMID: 23313424 BACKGROUND

• 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.

  PMID: 29680471 DERIVED

MeSH Terms

Conditions

Neurologic Manifestations; Premature Birth; Hypoxia-Ischemia, Brain

Interventions

Electroencephalography; Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Diagnostic Imaging; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Neonatal Research

Study Record Dates

• First Submitted: October 30, 2015
• First Posted: November 16, 2015
• Study Start: October 1, 2015
• Primary Completion: December 31, 2016
• Study Completion: May 13, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Locations

US (1)