Trial Outcomes & Findings for Neurodevelopmental Outcomes in Craniosynostosis Repair (NCT NCT04072783)
NCT ID: NCT04072783
Last Updated: 2026-04-22
Results Overview
Will establish pilot data to establish a normative curve of white-matter tract development in normal children under 4 years of age using (DTI). Fractional anisotropy (FA) (a main DTI parameter sensitive to white matter integrity) maps will be created to achieve a normative "white matter change curve" with from infancy to pre-school age.
TERMINATED
NA
9 participants
From 2 months age to 4 years of age
2026-04-22
Participant Flow
Participant milestones
| Measure |
Patients With Craniosynostosis
Patients with craniosynostosis will undergo pre - and post-operative imaging studies. The surgery will be performed for these patients as standard of care. They will also be tested fro neurodevelopment.
MRI,DTI, functional MRI: 1.Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography.
2.Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental.
3.Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4.
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|---|---|
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Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
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0
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Patients With Craniosynostosis
Patients with craniosynostosis will undergo pre - and post-operative imaging studies. The surgery will be performed for these patients as standard of care. They will also be tested fro neurodevelopment.
MRI,DTI, functional MRI: 1.Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography.
2.Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental.
3.Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4.
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|---|---|
|
Overall Study
subjects did not complete within protocol parameters
|
9
|
Baseline Characteristics
Neurodevelopmental Outcomes in Craniosynostosis Repair
Baseline characteristics by cohort
| Measure |
Patients With Craniosynostosis
n=9 Participants
Patients with craniosynostosis will undergo pre - and post-operative imaging studies. The surgery will be performed for these patients as standard of care. They will also be tested fro neurodevelopment.
MRI,DTI, functional MRI: 1.Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography.
2.Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental.
3.Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4.
|
|---|---|
|
Age, Categorical
<=18 years
|
9 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=60 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: From 2 months age to 4 years of agePopulation: The pre-specified number of scans required for analysis was not reached. Consequently, the study did not achieve a sufficient completion rate to support a robust statistical analysis.
Will establish pilot data to establish a normative curve of white-matter tract development in normal children under 4 years of age using (DTI). Fractional anisotropy (FA) (a main DTI parameter sensitive to white matter integrity) maps will be created to achieve a normative "white matter change curve" with from infancy to pre-school age.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From 2 months age to 4 years of agePopulation: The pre-specified number of scans required for analysis was not reached. Consequently, the study did not achieve a sufficient completion rate to support a robust statistical analysis.
Will quantify the change in white matter tract organization after cranial vault remodeling (CVR) surgery in patients with craniosynostosis by analyzing pre- and post-operative DTI data. This experimental cohort will also be examined in comparison to age-matched controls, pooled with other centers and compared with published data sets of normal babies from the Baby Connectome Project. . The imaging will be repeated at three intervals after surgery leading up to approximately 4 years of age.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 2 months of age to 4 years of agePopulation: The pre-specified number of scans required for analysis was not reached. Consequently, the study did not achieve a sufficient completion rate to support a robust statistical analysis.
Will assess neurodevelopmental test results in craniosynostosis patients and seek to correlate these findings with white matter tract changes
Outcome measures
Outcome data not reported
Adverse Events
Patients With Craniosynostosis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place