Characterization of the Functional and Structural Development of the Human Neonatal Brain From 30 Wks to 45 Wks ga

NCT02170142 | Completed DMC

• 2 other identifiers: NCT02170142R01MH092535
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The major goal of this project is to characterize the structural and functional development of cortical plate and white matter of the human neonatal brain from the equivalent 30 gestational weeks to 45 gestational weeks. The project is sponsored by niH R01MH092535. Furthermore, it is related to the blue print project of transcriptome atlas (niH RC2MH089921) with at least 36 million funding also sponsored by niH. Revealing detailed anatomy at different equivalent gestational ages of human neonatal brain not only aids in understanding this highly ordered process, but also provides clues to detect abnormalities caused by genetic or environmental factors. Cerebral vascular measurements offer important information on cerebral metabolism. However, either anatomical or functional studies of human brain development during this period are surprisingly scarce. Diffusion tensor imaging (DTi), a recently developed technology of magnetic resonance imaging (MRi), is capable of noninvasively delineating macroscopic anatomical components with high contrast and revealing structures at the microscopic level. Cerebral vascular quantification including cerebral blood flow (CBF) and cerebral metabolic rate of oxygen (CMRo2) can also be obtained through noninvasive MRi, specifically arterial spin labeling (aSL) and T2-relaxation under spin tagging (TRuST) MRi. in this proposed study, the structure and function of neonatal brain will be explored using noninvasive MRi technologies. 102 infants will be recruited and no sedation will be applied during MRi. The resultant database will provide reference standards for diagnostic radiology of premature newborns and reveal the vascular activities of these newborn brains. Specifically, three aims will be achieved:

1. 1.To delineate the anatomical development of complex structure in the cerebral wall and white matter tracts of neonatal brains at different equivalent gestational ages.
2. 2.To quantify the cerebral blood flow and metabolic rate of oxygen of neonatal brain.
3. 3.To correlate the structural and functional measurements with the gene transcriptome results.

Conditions

Human Development

Keywords

MRI; perinatal brain; development, neonates

Outcome Measures

Primary Outcomes (1)

• To observe normal brain development in neonates using MR imaging.

  neonates from 30 wg to 45 wg

Study Arms (1)

No treatment

All subjects studied are normal healthy neonates without a condition. MRI will be used to assess normal brain development.

Device: MRI

Interventions

MRI DEVICE

non-invasive MRI techniques (DTI) and (ASL) will be used to assess normal brain development. DTI is capable of invasively delineating macroscopic anatomic components with high contrast and revealing structures at the microscopic level. ASL is capable of measuring cerebral blood flow and cerebral metabolic rate of oxygen.

Also known as: 3T Philips Achieva MRI

No treatment

Eligibility Criteria

• Age: 30 Weeks - 45 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates in the neonatal intensive care unit at Parkland Hospital

You may qualify if:

• Normal infants of both genders
• Any race or ethnicity
• Inborn preterm delivered from 30-45 weeks gestation
• Medically stable for transport i.e. requiring at most a nasal canula \< 2 liters for respiratory support.

You may not qualify if:

• Infants not delivered from 30-45 weeks gestation
• Infants who may have a neurological event at birth
• Presence of known or suspected congenital anomalies such as chromosomal anomalies
• Major congenital heart disease or congenital infection
• Substance abuse and any grade\>1 of intraventricular hemorrhage (IVH) by cranial ultrasound
• Presence of cystic periventricular leukomalacia (PVL) by cranial ultrasound

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• Huang H, Jeon T, Sedmak G, Pletikos M, Vasung L, Xu X, Yarowsky P, Richards LJ, Kostovic I, Sestan N, Mori S. Coupling diffusion imaging with histological and gene expression analysis to examine the dynamics of cortical areas across the fetal period of human brain development. Cereb Cortex. 2013 Nov;23(11):2620-31. doi: 10.1093/cercor/bhs241. Epub 2012 Aug 28.

  PMID: 22933464 BACKGROUND

Related Links

• The BrainSpan atlas is a foundational resource for studying transcriptional mechanisms involved in human brain development.

Study Officials

• Hao Huang, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 23, 2014
• Study Start: February 1, 2012
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: September 9, 2019

Record last verified: 2019-09

Locations

US (1)