Magnetic Resonance Biomarkers in Neonatal Encephalopathy (MARBLE)

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Thayyil, Sudhin

Sponsor:

Information provided by (Responsible Party):

Sudhin Thayyil, Thayyil, Sudhin

ClinicalTrials.gov Identifier:

NCT01309711

First received: March 3, 2011

Last updated: February 20, 2015

Last verified: February 2015

History of Changes

Purpose

N-acetylaspartate (NAA) is a surrogate neuronal marker and its proton magnetic resonance spectroscopy (1H MRS) signal decreases with increasing neuronal mortality associated with cerebral hypoxia-ischaemia. The MRS lactate (Lac)/NAA peak-area ratio increases during and after severe cerebral hypoxia-ischaemia reflecting mitochondrial injury and impaired oxidative phosphorylation.

Aims: (1) To establish normative ranges for thalamic 1H MRS NAA concentration and Lac/NAA in healthy newborn infants (2) To examine the accuracies of thalamic 1H MRS NAA concentration and Lac/NAA for predicting adverse neurodevelopmental outcome in neonatal encephalopathy (NE)

Design: Prospective observational study Methods: Year 1: Following 1H MRS methodology optimisation 40 healthy control infants will be recruited to collect normative data. Year 2 to 3: 115 infants with NE, undergoing therapeutic hypothermia will be recruited. MRS will be performed aged less than 4 days and 7 to 14 days and thalamic NAA levels and Lac/NAA will be quantified; Qualitative interviews to evaluate parental understanding of this biomarker. Year 4, 5: Outcome assessment by BSID III at 18 months.

Outcomes: Mean thalamic NAA levels and Lac/NAA and appropriate confidence intervals in normal infants, and thalamic NAA levels and Lac/NAA in infants with NE according to neurodevelopmental outcome. Areas under curves for thalamic NAA and Lac/NAA will be examined separately for early & late MRS. Accuracy of early MRS will inform utility of this investigation in decisions about withdrawal of life support; late MRS will inform about efficacy as a surrogate end point in clinical trials. Qualitative interviews will be thematically analysed and reported.

Condition
Neonatal Encephalopathy


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Multicentre Prospective Study on Magnetic Resonance Biomarkers in Neonatal Encephalopathy

Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:

Prognostic accuracy of [NAA] [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Assessed by BSID 3

Biospecimen Retention: Samples With DNA

Blood and urine


Estimated Enrollment:	180
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts
HIE Moderate of severe neonatal encephalopathy

Show Detailed Description

Eligibility


Ages Eligible for Study:	up to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Healthy control infants, Infants with Neonatal encephalopathy, Healthy adult volunteers

Criteria

Inclusion Criteria:

Group I (Controls): Healthy newborn infants (gestation 36 to 43 weeks, birth weight >2.7 kg)
Group II (NE): Infants 36 to 43 weeks gestation with at least one of the following:
- Evidence of perinatal asphyxia as indicated by
- Apgar score of <5 at 5 minutes after birth
- Continued need for resuscitation, including endotracheal or mask ventilation, at 5 minutes after birth
- Acidosis defined as pH <7.00 and/or base deficit >16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood) AND
Moderate to severe encephalopathy consisting of altered state of consciousness (reduced or absent response to stimulation) and hypotonia, and abnormal primitive reflexes (weak or absent suck or Moro response). Clinical NE severity will be assessed by Thompson encephalopathy score.
Group III (Healthy adult volunteers): Same individual will be scanned multiple times at each of the centres to examine intra and inter-centre variability of thalamic [NAA].

Exclusion Criteria:

Life threatening congenital malformations
Syndromic infants
Metabolic disorders
Meningitis or encephalitis

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309711

Contacts


Contact: Sudhin Thayyil, PhD	00447912888700	s.thayyil@imperial.ac.uk

Locations


United Kingdom
Sudhin Thayyil	Recruiting
London, United Kingdom
Contact: Sudhin Thayyil, PhD

Sponsors and Collaborators

Thayyil, Sudhin

More Information

No publications provided


Responsible Party:	Sudhin Thayyil, Consultant Neonatologist, Thayyil, Sudhin
ClinicalTrials.gov Identifier:	NCT01309711 History of Changes
Other Study ID Numbers:	MARBLE
Study First Received:	March 3, 2011
Last Updated:	February 20, 2015
Health Authority:	United Kingdom: National Institute for Health Research

Keywords provided by Thayyil, Sudhin:


MRI Biomarkers Neonatal encephalopathy Therapeutic hypothermia

Additional relevant MeSH terms:


Brain Diseases Central Nervous System Diseases Nervous System Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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