Functional Imaging of Baby Brains

NCT05514665 | Recruiting

• 1 other identifier: NIF-22535
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Infants are at risk of developing motor and cognitive neurodevelopmental disabilities as a sequelae to hypoxic-ischemic brain injury during the perinatal period. It is an ongoing challenge to predict the severity and extent of future developmental impairment during the neonatal period. This study will help test the feasibility of conducting a large-scale study that evaluates the role of diffuse optical tomography as a bedside neuroimaging tool in complementing the prognostic value of conventional and diffusion weighted MRI for predicting neurodevelopmental outcome in neonates with perinatal hypoxic-ischemic brain injury.

Conditions

Hypoxia Ischemia, Cerebral; Hypoxia-Ischemia, Brain; Hypoxia Neonatal; Hypoxic-Ischemic Encephalopathy

Keywords

diffuse optical tomography; functional near-infrared spectroscopy; neuroimaging; functional connectivity; resting state networks

Outcome Measures

Primary Outcomes (4)

• Consent rate

  An eligible patient (parents or substitute decision makers) consents to the study

  12 months

• Rate of completion of study intervention

  An enrolled patient receives DOT measurements taken within 7 days of life

  12 months

• Rate of successful data acquisition

  An enrolled patient completes resting state DOT data acquisition within 45 mins without sedation

  12 months

• Rate of developmental follow up

  An enrolled patient is assessed for neurological outcome at the age of 6 months and 12 months

  12 months

Secondary Outcomes (3)

• Resting state connectivity measures

  12 months

• First time-point developmental assessment

  6 months post menstrual age

• Second time-point developmental assessment

  12 months post menstrual age

Study Arms (1)

Neonates with perinatal hypoxic-ischemic brain injury

Neonates who are admitted to the Level III Neonatal Intensive Care Unit with a diagnosis of hypoxic ischemic encephalopathy will undergo diffuse optical tomography measurements prior to discharge from Neonatal Intensive Care Unit . Their developmental assessment will be performed at 6 months and 12 months postmenstrual age.

Device: Diffuse Optical Tomography

Interventions

Diffuse Optical Tomography DEVICE

Neonates once hemodynamically stable will undergo diffuse optical tomography measurements of functional brain connectivity at the bedside within 3-7 days after birth.

Neonates with perinatal hypoxic-ischemic brain injury

Eligibility Criteria

• Age: 1 Day - 15 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of neonates admitted with clinical history suggestive of perinatal hypoxic-ischemic encephalopathy will be enrolled to the study, irrespective of whether they are considered eligible or ineligible for therapeutic hypothermia. The intervention (DOT measurement) will be conducted after therapeutic hypothermia is completed and neonate is considered hemodynamically stable to tolerate the procedure.

You may qualify if:

• Newborns admitted to the McMaster Children's Hospital Neonatal Intensive Care Unit with the diagnosis of hypoxic-ischemic encephalopathy will be considered for this study
• Gestational age of 35 weeks or greater
• Birth weight more than 1.8 Kg

You may not qualify if:

• (i) suspected or confirmed congenital malformations, (ii) chromosomal anomalies, (iii) inborn errors of metabolism, (iv) congenital infections, (v) neonatal encephalopathy other than HIE, (vi) baby requires respiratory support in the form of CPAP, Mechanical ventilation, high flow nasal cannula and (vii) scalp injury or non-intact skin surface in the scalp

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead
• McMaster University: collaborator

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8N3Z5, Canada

RECRUITING

Related Publications (10)

• Doria V, Beckmann CF, Arichi T, Merchant N, Groppo M, Turkheimer FE, Counsell SJ, Murgasova M, Aljabar P, Nunes RG, Larkman DJ, Rees G, Edwards AD. Emergence of resting state networks in the preterm human brain. Proc Natl Acad Sci U S A. 2010 Nov 16;107(46):20015-20. doi: 10.1073/pnas.1007921107. Epub 2010 Nov 1.

  PMID: 21041625 BACKGROUND

• Gao W, Alcauter S, Elton A, Hernandez-Castillo CR, Smith JK, Ramirez J, Lin W. Functional Network Development During the First Year: Relative Sequence and Socioeconomic Correlations. Cereb Cortex. 2015 Sep;25(9):2919-28. doi: 10.1093/cercor/bhu088. Epub 2014 May 8.

  PMID: 24812084 BACKGROUND

• Fransson P, Skiold B, Horsch S, Nordell A, Blennow M, Lagercrantz H, Aden U. Resting-state networks in the infant brain. Proc Natl Acad Sci U S A. 2007 Sep 25;104(39):15531-6. doi: 10.1073/pnas.0704380104. Epub 2007 Sep 18.

  PMID: 17878310 BACKGROUND

• Gollenberg AL, Lynch CD, Jackson LW, McGuinness BM, Msall ME. Concurrent validity of the parent-completed Ages and Stages Questionnaires, 2nd Ed. with the Bayley Scales of Infant Development II in a low-risk sample. Child Care Health Dev. 2010 Jul;36(4):485-90. doi: 10.1111/j.1365-2214.2009.01041.x. Epub 2009 Dec 16.

  PMID: 20030657 BACKGROUND

• Ferradal SL, Liao SM, Eggebrecht AT, Shimony JS, Inder TE, Culver JP, Smyser CD. Functional Imaging of the Developing Brain at the Bedside Using Diffuse Optical Tomography. Cereb Cortex. 2016 Apr;26(4):1558-68. doi: 10.1093/cercor/bhu320. Epub 2015 Jan 16.

  PMID: 25595183 BACKGROUND

• Liao SM, Gregg NM, White BR, Zeff BW, Bjerkaas KA, Inder TE, Culver JP. Neonatal hemodynamic response to visual cortex activity: high-density near-infrared spectroscopy study. J Biomed Opt. 2010 Mar-Apr;15(2):026010. doi: 10.1117/1.3369809.

  PMID: 20459255 BACKGROUND

• Niu H, Li Z, Liao X, Wang J, Zhao T, Shu N, Zhao X, He Y. Test-retest reliability of graph metrics in functional brain networks: a resting-state fNIRS study. PLoS One. 2013 Sep 9;8(9):e72425. doi: 10.1371/journal.pone.0072425. eCollection 2013.

  PMID: 24039763 BACKGROUND

• Lee CW, Cooper RJ, Austin T. Diffuse optical tomography to investigate the newborn brain. Pediatr Res. 2017 Sep;82(3):376-386. doi: 10.1038/pr.2017.107. Epub 2017 May 31.

  PMID: 28419082 BACKGROUND

• Smyser CD, Wheelock MD, Limbrick DD Jr, Neil JJ. Neonatal brain injury and aberrant connectivity. Neuroimage. 2019 Jan 15;185:609-623. doi: 10.1016/j.neuroimage.2018.07.057. Epub 2018 Jul 27.

  PMID: 30059733 BACKGROUND

• Zhang X, Toronov V, Webb A. Simultaneous integrated diffuse optical tomography and functional magnetic resonance imaging of the human brain. Opt Express. 2005 Jul 11;13(14):5513-21. doi: 10.1364/opex.13.005513.

  PMID: 19498547 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia Neonatorum

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ipsita Goswami, MD, MSc

CONTACT

9055212100; goswamii@mcmaster.ca

Gabriel Xiao, PhD

CONTACT

9055259140; xiao8@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 24, 2022
• Study Start: March 15, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: October 23, 2024

Record last verified: 2024-03

Locations

CA (1)