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Infant, PrematureNCT00153855

Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates

An observational study of Infant, Premature and Brain Injuries, run by Children's Hospital of Philadelphia at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants. Read more about this study

Who is it for?
Ages 24 to 27 monthsHealthy volunteers can take part
Conditions the study is for
Infant, Premature, Brain Injuries
How many people
50 participants
Where
3 sitesUnited States
Study dates
Jan 2005to Mar 2006
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 24 to 27 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • must be participants in trial (NHLBI-UO1-HL62514-05A1 and FDA IND # 58,146 - Roberta A Ballard PI) of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants
  • gestational age between 24 months and 27 months

Who cannot join

  • history of allergy to sedation agents
  • medical conditions which may pose a threat to airway integrity (i.e., Pierre-Robin sequence, intercurrent respiratory illness)
  • other conditions which may otherwise place subjects at increased risk for complications from sedation and MRI examination

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Children's Hospital Boston

    Boston, Massachusetts, 02115

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants. It is hypothesized that this imaging will identify children with previously undiagnosed brain abnormalities and that the presence of structural abnormalities will be associated with deficits in motor, cognitive, and neurosensory development.

Read the detailed description

Infants born prematurely are at significant risk for hemorrhagic and ischemic brain injury. Despite improved survival rates among this population in recent years, these forms of brain injury remain frequent and have considerable consequences. Periventricular leukomalacia (PVL), a disease characterized by necrosis of the cerebral white matter in a characteristic distribution, is one of the most common types of brain injury seen in premature infants. MRI technology now allows for better anatomical resolution resulting in improvements in diagnostic accuracy. The current standard practice is not to perform routine MRI examinations on premature infants, nor is it routine to perform surveillance brain imaging in children after leaving the NICU. In their 2002 Practice Parameter for neuroimaging in the neonate, the American Academy of Neurology and the Practice Committee of the Child Neurology Society acknowledge the superiority of MRI in detection of brain lesions in premature infants, but fall short of recommending routine MRI scanning on the basis of a lack of information correlating MRI findings to neurodevelopmental outcomes. We now have a unique opportunity to help provide such information.

Keywords
etiology, pathology
Medical subject headings
Premature Birth, Brain Injuries

Timeline

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

  1. First posted12 Sep 2005 (estimated)
  2. Study startJan 2005
  3. Study completionMar 2006

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
Defined population
Time perspective
Prospective
Enrolment
50 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153855
Sponsor's protocol ID
2004-6-3818
Status last verified
Sep 2006
First submitted
8 Sep 2005
Last updated
8 Sep 2006
Results posted
No

Publications

  • Stevenson DK, Wright LL, Lemons JA, Oh W, Korones SB, Papile LA, Bauer CR, Stoll BJ, Tyson JE, Shankaran S, Fanaroff AA, Donovan EF, Ehrenkranz RA, Verter J. Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, January 1993 through December 1994. Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1632-9. doi: 10.1016/s0002-9378(98)70037-7.

    PubMed 9855609

  • Volpe JJ. Brain injury in the premature infant: overview of clinical aspects, neuropathology, and pathogenesis. Semin Pediatr Neurol. 1998 Sep;5(3):135-51. doi: 10.1016/s1071-9091(98)80030-2.

    PubMed 9777673

  • Hack M, Fanaroff AA. Outcomes of children of extremely low birthweight and gestational age in the 1990s. Semin Neonatol. 2000 May;5(2):89-106. doi: 10.1053/siny.1999.0001.

    PubMed 10859704

  • Bhutta AT, Cleves MA, Casey PH, Cradock MM, Anand KJ. Cognitive and behavioral outcomes of school-aged children who were born preterm: a meta-analysis. JAMA. 2002 Aug 14;288(6):728-37. doi: 10.1001/jama.288.6.728.

    PubMed 12169077

  • Sie LT, van der Knaap MS, van Wezel-Meijler G, Taets van Amerongen AH, Lafeber HN, Valk J. Early MR features of hypoxic-ischemic brain injury in neonates with periventricular densities on sonograms. AJNR Am J Neuroradiol. 2000 May;21(5):852-61.

    PubMed 10815660

  • Inder TE, Huppi PS, Warfield S, Kikinis R, Zientara GP, Barnes PD, Jolesz F, Volpe JJ. Periventricular white matter injury in the premature infant is followed by reduced cerebral cortical gray matter volume at term. Ann Neurol. 1999 Nov;46(5):755-60. doi: 10.1002/1531-8249(199911)46:53.0.co;2-0.

    PubMed 10553993

  • Olsen P, Paakko E, Vainionpaa L, Pyhtinen J, Jarvelin MR. Magnetic resonance imaging of periventricular leukomalacia and its clinical correlation in children. Ann Neurol. 1997 Jun;41(6):754-61. doi: 10.1002/ana.410410611.

    PubMed 9189036

  • Inder TE, Wells SJ, Mogridge NB, Spencer C, Volpe JJ. Defining the nature of the cerebral abnormalities in the premature infant: a qualitative magnetic resonance imaging study. J Pediatr. 2003 Aug;143(2):171-9. doi: 10.1067/S0022-3476(03)00357-3.

    PubMed 12970628

  • Huppi PS, Murphy B, Maier SE, Zientara GP, Inder TE, Barnes PD, Kikinis R, Jolesz FA, Volpe JJ. Microstructural brain development after perinatal cerebral white matter injury assessed by diffusion tensor magnetic resonance imaging. Pediatrics. 2001 Mar;107(3):455-60. doi: 10.1542/peds.107.3.455.

    PubMed 11230582

  • Huppi PS, Maier SE, Peled S, Zientara GP, Barnes PD, Jolesz FA, Volpe JJ. Microstructural development of human newborn cerebral white matter assessed in vivo by diffusion tensor magnetic resonance imaging. Pediatr Res. 1998 Oct;44(4):584-90. doi: 10.1203/00006450-199810000-00019.

    PubMed 9773850

  • Hoon AH Jr, Lawrie WT Jr, Melhem ER, Reinhardt EM, Van Zijl PC, Solaiyappan M, Jiang H, Johnston MV, Mori S. Diffusion tensor imaging of periventricular leukomalacia shows affected sensory cortex white matter pathways. Neurology. 2002 Sep 10;59(5):752-6. doi: 10.1212/wnl.59.5.752.

    PubMed 12221171

  • Miller SP, Vigneron DB, Henry RG, Bohland MA, Ceppi-Cozzio C, Hoffman C, Newton N, Partridge JC, Ferriero DM, Barkovich AJ. Serial quantitative diffusion tensor MRI of the premature brain: development in newborns with and without injury. J Magn Reson Imaging. 2002 Dec;16(6):621-32. doi: 10.1002/jmri.10205.

    PubMed 12451575

  • Inder TE, Volpe JJ. Mechanisms of perinatal brain injury. Semin Neonatol. 2000 Feb;5(1):3-16. doi: 10.1053/siny.1999.0112.

    PubMed 10802746

  • Melhem ER, Hoon AH Jr, Ferrucci JT Jr, Quinn CB, Reinhardt EM, Demetrides SW, Freeman BM, Johnston MV. Periventricular leukomalacia: relationship between lateral ventricular volume on brain MR images and severity of cognitive and motor impairment. Radiology. 2000 Jan;214(1):199-204. doi: 10.1148/radiology.214.1.r00dc35199.

    PubMed 10644124

  • Ment LR, Bada HS, Barnes P, Grant PE, Hirtz D, Papile LA, Pinto-Martin J, Rivkin M, Slovis TL. Practice parameter: neuroimaging of the neonate: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2002 Jun 25;58(12):1726-38. doi: 10.1212/wnl.58.12.1726.

    PubMed 12084869

Questions about this trial

What is this clinical trial studying?

An observational study of Infant, Premature and Brain Injuries, run by Children's Hospital of Philadelphia at 3 sites 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 2 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: stopped early, as of the sponsor's last update on 8 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was stopped early. Results are not available in the source record.

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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00153855, which also lists 22 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 8 Sep 2006.

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