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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: Clinical Trial NA study, sponsored by Boston Children's Hospital.
NCT01218087 is a NA study that was terminated before completion, run by Boston Children's Hospital. The registered enrollment target is 88 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of\<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.
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 |
Why NCT01218087 stopped before completion
NCT01218087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Cranial cup device and Moldable positioner is the first listed.
NCT01218087 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01218087's enrollment target sits among peer trials
88 972nd of 2000 higher than 1,027 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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