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

NCT01218087 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2017-02-03

Study results available
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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.

Conditions

  • Plagiocephaly
  • Scaphocephaly
  • Brachycephaly

Interventions

DEVICE

Cranial cup device and Moldable positioner

The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in hospitalized infants

DEVICE

Moldable positioner device

This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.

Sponsors & Collaborators

Principal Investigators

  • Michele DeGrazia, PhD, NNP · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
10 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01218087 on ClinicalTrials.gov