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Child and Infant Learning Project (CILP)

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 16, 2004
Last Update Posted: July 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Matt Speltz, Seattle Children's Hospital
To learn more about the cognitive and motor development of infants and young children born with a craniofacial defect called craniosynostosis.

Condition Intervention
Craniosynostosis Behavioral: neurobehavioral development

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Neurobehavioral Correlates of Craniosynostosis

Resource links provided by NLM:

Further study details as provided by Matt Speltz, Seattle Children's Hospital:

Primary Outcome Measures:
  • Neurodevelopment as assessed by the Bayley Scales of Infant Development II [ Time Frame: 1st assessment - post diagnosis, pre surgery. 2nd assessment - Target age 18 months. 3rd assessment - Target age 36 months. ]

Secondary Outcome Measures:
  • Neurodevelopment as assessed by the Wechsler Intelligence Scale for Children Version IV [ Time Frame: Target age 7 years ]

Enrollment: 535
Study Start Date: September 2001
Study Completion Date: June 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: neurobehavioral development
    observational study of infant and child development
Detailed Description:
In the first phase of this multi-site, 10-year longitudinal study, infants with one of four types of single-suture craniosynostosis were recruited: sagittal, metopic, right unilateral coronal, and left unilateral coronal. A case-matched "control" group of healthy, normal infants was also followed. This study, which is now in its second phase, is following this same cohort of children at the age of 7 years.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children with single-suture craniosynostosis between the ages of 2 months and 3 years were recruited and followed during phase 1. This same chort of children are now being followed at the age of 7 (phase 2). See eligibility criteria section for more information.

Enrollment criteria at Phase 1:

  • Confirmed diagnosis of single-suture, nonsyndromic craniosynostosis (sagittal, metopic, unilateral coronal, or lambdoid)
  • Corrective (cranioplastic) surgery not yet performed
  • Child born at 34 weeks gestation or later
  • Absence of neurological conditions/significant health problems
  • 33 months or younger at time of enrollment (male or female).

Enrollment criteria at Phase 2:

All participants enrolled in phase 1 are invited to participate in phase 2.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00077831

United States, Georgia
Children's Health Care of Atlanta
Atlanta, Georgia, United States, 30342
United States, Illinois
Northwestern University, Cleft Lip and Palate Institute
Westchester, Illinois, United States, 60154
United States, Missouri
St. Louis Children's Hospital / Washington University
St. Louis, Missouri, United States, 63110
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
National Institute of Dental and Craniofacial Research (NIDCR)
Principal Investigator: Matthew L. Speltz Seattle Children's Hospital
  More Information

Starr JR, Kapp-Simon KA, Cloonan YK, Collett BR, Cradock MM, Buono L, Cunningham ML, Speltz ML. Presurgical and postsurgical assessment of the neurodevelopment of infants with single-suture craniosynostosis: comparison with controls. J Neurosurg. 2007 Aug;107(2 Suppl):103-10. doi: 10.3171/PED-07/08/103.
Lin HJ, Ruiz-Correa S, Shapiro LG, Speltz ML, Cunningham ML, Sze RW. Predicting neuropsychological development from skull imaging. Conf Proc IEEE Eng Med Biol Soc. 2006;1:3450-5.
Ruiz-Correa S, Starr JR, Lin HJ, Kapp-Simon KA, Cunningham ML, Speltz ML. Severity of skull malformation is unrelated to presurgery neurobehavioral status of infants with sagittal synostosis. Cleft Palate Craniofac J. 2007 Sep;44(5):548-54.
Toth K, Collett B, Kapp-Simon KA, Cloonan YK, Gaither R, Cradock MM, Buono L, Cunningham ML, Dawson G, Starr J, Speltz ML. Memory and response inhibition in young children with single-suture craniosynostosis. Child Neuropsychol. 2008 Jul;14(4):339-52. doi: 10.1080/09297040701594888. Epub 2007 Sep 26.
Kapp-Simon KA, Speltz ML, Cunningham ML, Patel PK, Tomita T. Neurodevelopment of children with single suture craniosynostosis: a review. Childs Nerv Syst. 2007 Mar;23(3):269-81. Epub 2006 Dec 21. Review.
Kapp-Simon KA, Leroux B, Cunningham M, Speltz ML. Multisite study of infants with single-suture craniosynostosis: preliminary report of presurgery development. Cleft Palate Craniofac J. 2005 Jul;42(4):377-84.
Ruiz-Correa S, Sze RW, Starr JR, Lin HT, Speltz ML, Cunningham ML, Hing AV. New scaphocephaly severity indices of sagittal craniosynostosis: a comparative study with cranial index quantifications. Cleft Palate Craniofac J. 2006 Mar;43(2):211-21.
Cunningham ML, Horst JA, Rieder MJ, Hing AV, Stanaway IB, Park SS, Samudrala R, Speltz ML. IGF1R variants associated with isolated single suture craniosynostosis. Am J Med Genet A. 2011 Jan;155A(1):91-7. doi: 10.1002/ajmg.a.33781.
Kapp-Simon KA, Collett BR, Barr-Schinzel MA, Cradock MM, Buono LA, Pietila KE, Speltz ML. Behavioral adjustment of toddler and preschool-aged children with single-suture craniosynostosis. Plast Reconstr Surg. 2012 Sep;130(3):635-47.
Mefford HC, Shafer N, Antonacci F, Tsai JM, Park SS, Hing AV, Rieder MJ, Smyth MD, Speltz ML, Eichler EE, Cunningham ML. Copy number variation analysis in single-suture craniosynostosis: multiple rare variants including RUNX2 duplication in two cousins with metopic craniosynostosis. Am J Med Genet A. 2010 Sep;152A(9):2203-10. doi: 10.1002/ajmg.a.33557.
Naumann HL, Haberkern CM, Pietila KE, Birgfeld CB, Starr JR, Kapp-Simon KA, Hopper RA, Speltz ML. Duration of exposure to cranial vault surgery: associations with neurodevelopment among children with single-suture craniosynostosis. Paediatr Anaesth. 2012 Nov;22(11):1053-61. doi: 10.1111/j.1460-9592.2012.03843.x.
Rosenberg JM, Kapp-Simon KA, Starr JR, Cradock MM, Speltz ML. Mothers' and fathers' reports of stress in families of infants with and without single-suture craniosynostosis. Cleft Palate Craniofac J. 2011 Sep;48(5):509-18. doi: 10.1597/09-210. Epub 2010 Aug 19.
Ruiz-Correa S, Starr JR, Lin HJ, Kapp-Simon KA, Sze RW, Ellenbogen RG, Speltz ML, Cunningham ML. New severity indices for quantifying single-suture metopic craniosynostosis. Neurosurgery. 2008 Aug;63(2):318-24; discussion 324-5. doi: 10.1227/01.NEU.0000316417.06500.DA.
Seto ML, Hing AV, Chang J, Hu M, Kapp-Simon KA, Patel PK, Burton BK, Kane AA, Smyth MD, Hopper R, Ellenbogen RG, Stevenson K, Speltz ML, Cunningham ML. Isolated sagittal and coronal craniosynostosis associated with TWIST box mutations. Am J Med Genet A. 2007 Apr 1;143A(7):678-86.
Speltz ML, Kapp-Simon K, Collett B, Keich Y, Gaither R, Cradock MM, Buono L, Cunningham ML. Neurodevelopment of infants with single-suture craniosynostosis: presurgery comparisons with case-matched controls. Plast Reconstr Surg. 2007 May;119(6):1874-81.
Starr JR, Collett BR, Gaither R, Kapp-Simon KA, Cradock MM, Cunningham ML, Speltz ML. Multicenter study of neurodevelopment in 3-year-old children with and without single-suture craniosynostosis. Arch Pediatr Adolesc Med. 2012 Jun 1;166(6):536-42. doi: 10.1001/archpediatrics.2011.1800.
Starr JR, Lin HJ, Ruiz-Correa S, Cunningham ML, Ellenbogen RG, Collett BR, Kapp-Simon KA, Speltz ML. Little evidence of association between severity of trigonocephaly and cognitive development in infants with single-suture metopic synostosis. Neurosurgery. 2010 Aug;67(2):408-15; discussion 415-6. doi: 10.1227/01.NEU.0000371992.72539.8B.
Collett BR, Gray KE, Kapp-Simon KA, Birgfeld C, Cunningham M, Rudo-Stern J, Ung D, Buono L, Speltz ML. Laypersons' ratings of appearance in children with and without single-suture craniosynostosis. J Craniofac Surg. 2013 Jul;24(4):1331-5. doi: 10.1097/SCS.0b013e3182997885.
Gray KE, Cradock MM, Kapp-Simon KA, Collett BR, Pullmann LD, Speltz ML. Longitudinal analysis of parenting stress in mothers and fathers of infants with and without single-suture craniosynostosis. Cleft Palate Craniofac J. 2015 Jan;52(1):3-11. doi: 10.1597/13-239.
Speltz ML, Kapp-Simon KA, Cunningham M, Marsh J, Dawson G. Single-suture craniosynostosis: a review of neurobehavioral research and theory. J Pediatr Psychol. 2004 Dec;29(8):651-68. Review.
McCarthy JG, Warren SM, Bernstein J, Burnett W, Cunningham ML, Edmond JC, Figueroa AA, Kapp-Simon KA, Labow BI, Peterson-Falzone SJ, Proctor MR, Rubin MS, Sze RW, Yemen TA; Craniosynostosis Working Group. Parameters of care for craniosynostosis. Cleft Palate Craniofac J. 2012 Jan;49 Suppl:1S-24S. doi: 10.1597/11-138. Epub 2011 Aug 17.

Responsible Party: Matt Speltz, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT00077831     History of Changes
Other Study ID Numbers: NIDCR-13813
R01DE013813 ( U.S. NIH Grant/Contract )
First Submitted: February 12, 2004
First Posted: February 16, 2004
Last Update Posted: July 21, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Congenital Abnormalities

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