N/A
Completed N=23
Cranial Cup Use for Correction of Head Shape Deformities
Dolichocephaly
Source: ClinicalTrials.gov NCT01683812 ↗
Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Feasibility and Safety — 7; 1 count
Summary
The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility and Safety |
7; 1 | — |
| SECONDARY Cranial Measurement Description |
77.5 | — |
Eligibility Criteria
Inclusion Criteria
- Born at 14 days
- Weight >1000 grams (at enrollment)
- Dolichocephalic head shape deformity
Exclusion Criteria
- Unable to maintain airway patency (anatomical problem)
- Craniofacial anomaly or scalp device, drain or shunt
- Craniosynostosis
- Severe parturitional head shape deformity
Data sourced from ClinicalTrials.gov (NCT01683812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.