Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01683812 · ClinicalTrials.gov registry record · NA
Cranial Cup Use for Correction of Head Shape Deformities
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT01683812: Completed NA study, sponsored by Boston Children's Hospital.
NCT01683812 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01683812, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of \< 90 percent for infant corrected to full term or \< 87 percent for a premature infant for \> 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation even
Interventions
- DEVICE Cranial Cup
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-06 |
| Phase | NA |
What the finished NCT01683812 record still lists
NCT01683812 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cranial Cup is the first listed.
NCT01683812 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01683812 about?
NCT01683812 is a clinical study titled "Cranial Cup Use for Correction of Head Shape Deformities". 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 hospitalizat...
What is the current status of trial NCT01683812?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2012-05. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01683812?
The interventions under investigation include: Cranial Cup (DEVICE).
Who is sponsoring clinical trial NCT01683812?
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 NCT01683812's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03616041 · 23 participants
Capsule Endoscopy for Severe Hematochezia
- NCT04348747 · 23 participants · Phase 2
Dendritic Cell Vaccines Against Her2/Her3 and Pembrolizumab for the Treatment of Brain Metastasis From Triple Negative Breast Cancer or HER2+ Breast Cancer
- NCT04587687 · 23 participants · Phase 2
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
- NCT04715022 · 23 participants · Phase 1
Sympathetic-vascular Dysfunction in Obesity and Insulin Resistance (Vitamin C Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia