Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

Stopped early · Not applicable

Conditions studied: Plagiocephaly, Scaphocephaly, Brachycephaly

In brief

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.

Key facts

Study ID

NCT01218087

Run by

Boston Children's Hospital

People needed

88

Starts

2010-04-01

Expected to finish

2012-07-01

Last updated by the study team

2017-02-03

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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