Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU (NCT01218087) | Clinical Trial Compass
TerminatedNot Applicable
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
Stopped: Study discontinued by DSMB due to loss of equipoise.
United States88 participantsStarted 2010-04
Plain-language 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.
Who can participate
Age range
10 Days
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Infants born at \>/= 22 weeks gestation
. Infant that are \</= 7 days of age
. Infants that receive medical clearance from their healthcare team
. Infants that have an estimated minimum NICU length of stay = / \> 14 days from the time of enrollment
Exclusion criteria
. Infants that require only prone positioning to maintain airway patency (such as those with Pierre Robin Syndrome/Sequence) will not be eligible to participate; this is because infants must be able to lie supine for at least part of the day to use the cranial cup
. Infants requiring medical devices such as a continuous ventricular drain, subgaleal shunt, or intravenous catheters (unless placement of the IV is temporary) prevent proper positioning using the cranial cup
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cranial Abnormalities Were Measured at Hospital Discharge
. Infants with a craniofacial anomaly, cervical anomaly, or critical airway infants
. Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the cranial cup may worsen a preexisting condition
. Infants with a prenatal diagnosis of craniosynostosis
. Infants deemed not suitable for participation by the attending neonatologist
. Infants that are to be transferred to a non-participating hospital within 14 days of enrollment as this timeframe may not be adequate to show a difference in head shapes