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Neurologic ManifestationsNeu-PremNCT02605733

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

An observational study of Neurologic Manifestations and Premature Birth, run by Sharp HealthCare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 72 hours
What is being tested?
EEG and NIRS
Type of treatment
Medical device
How many people
130 participants
Where
1 siteUnited States
Study dates
Oct 2015to 13 May 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 72 hours
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 23 to 31+6 weeks gestational age at birth

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sharp Mary Birch Hospital for Women and Newborns

    San Diego, California, 92123

Other trials in United States

About this study

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.

Read the 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.

Being tested
EEG, NIRS
Keywords
Premature infant, Amplitude integrated EEG, Near-infrared spectroscopy
Medical subject headings
Neurologic Manifestations, Premature Birth, Hypoxia-Ischemia, Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EEGDevice

    Also called amplitude integrated electroencephalography

    amplitude integrated electroencephalography

  • NIRSDevice

    Also called Near-infrared spectroscopy

    regional tissue oximetry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EEG

    amplitude integrated EEG to measure brain activity

    Measured: Birth to 72 hours of life

  2. NIRS

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

    Measured: Birth to 72 hours of life

Secondary outcomes (13)

  1. Apgar scores

    1 and 5 minute Apgar scores

    Measured: 1, 5 and 10 minutes of life if applicable

  2. Cord gases

    Arterial or venous pH (acid/base), base deficit

    Measured: Upon delivery

  3. Resuscitation intervention

    Fraction of inspired oxygen (FiO2), cpap, positive pressure ventilation (PPV), intubations.

    Measured: From birth to 10 minutes of life

  4. Maximum FiO2

    Maximum FiO2 during resuscitation at birth

    Measured: From birth to 10 minutes of life

  5. Maximum peak inspiratory pressure

    Peak inspiratory pressure of respiratory support

    Measured: From birth to 10 minutes of life

  6. Heart rate

    Measured: Birth to 72 hours of life

  7. Heart rate by EKG during resuscitation (substudy)

    A substudy of 40 infants will have EKG leads placed on newborns during resuscitation; 20 will have the display blinded, and 20 will have values available to the team. The amount of resuscitation (mean airway pressure FiO2 will be compared between groups).

    Measured: Birth

  8. Cardiac output

    Measured: From neonatal intensive care unit (NICU) admission through 72 hours of life

  9. Mean arterial blood pressure

    Measured: From NICU admission through 72 hours of life

  10. Use of cardiac inotropes

    Dopamine, dobutamine, epinephrine

    Measured: From birth through discharge to home, up to 9 months of age

  11. Head Ultrasound

    Cranial ultrasonography

    Measured: Within 24 hours of life and at approximately 72 hours of life

  12. MRI

    Presence of brain injury (e.g. intraventricular hemorrhage (IVH), (PVL)

    Measured: From birth through discharge to home, up to 9 months of age

  13. Neurodevelopmental impairment at 2 year follow up

    Neurodevelopmental assessment at 2 year corrected gestational age

    Measured: 18 to 30 months corrected gestational age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion31 Dec 2016
  4. Study completion13 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02605733
Sponsor's protocol ID
Neu-Prem
Acronym
Neu-Prem
Status last verified
Dec 2021
First submitted
30 Oct 2015
Last updated
13 Dec 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25594221

  • 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.

    PubMed 18650042

  • 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.

    PubMed 22082686

  • 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.

    PubMed 21741190

  • 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.

    PubMed 19150756

  • 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.

    PubMed 20877412

  • 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.

    PubMed 21852771

  • 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.

    PubMed 24560179

  • 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.

    PubMed 24709780

  • 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.

    PubMed 24183212

  • 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.

    PubMed 22254711

  • 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.

    PubMed 25003781

  • 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.

    PubMed 24867393

  • 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.

    PubMed 23313424

  • 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.

    PubMed 29680471

Questions about this trial

What is this clinical trial studying?

An observational study of Neurologic Manifestations and Premature Birth, run by Sharp HealthCare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EEG (time frame: Birth to 72 hours of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02605733, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.

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