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NCT01218087 · ClinicalTrials.gov registry record · NA
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
A NA study, sponsored by Boston Children's Hospital.
- Terminated
- Registry status
- NA
- Development phase
- 88
- Enrollment target
NCT01218087 is a NA study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 88 participants.
The verdict
NCT01218087, a NA study, was terminated before completion, sponsored by Boston Children's Hospital.
- TERMINATED
- Registry status
- NA
- Development phase
- 88 participants
- Enrollment target
Study Summary
Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they may spend longer periods of time in a crib. Infants participating in this study will be randomly assigned to either standard treatment, which is a moldable positioner device, or to a cranial cup device and moldable positioner for positioning. The purpose of this prospective single-blinded randomized clinical trial will be to evaluate the effectiveness of the cranial cup in preventing positional head shape deformity in the NICU patient population.
Interventions
- DEVICE Cranial cup device and Moldable positioner
- DEVICE Moldable positioner device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2010-04 |
| Est. Completion | 2012-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01218087
The ClinicalTrials.gov registry entry for NCT01218087 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cranial cup device and Moldable positioner is the first listed.
NCT01218087 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01218087 about?
NCT01218087 is a clinical study titled "Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU". Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they...
What is the current status of trial NCT01218087?
This trial is currently terminated. It is a NA study. The enrollment target is 88 participants. The study started on 2010-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01218087?
The interventions under investigation include: Cranial cup device and Moldable positioner (DEVICE), Moldable positioner device (DEVICE).
Who is sponsoring clinical trial NCT01218087?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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