Text Size

Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU (cranial cup)

This study is currently recruiting participants.
Verified August 2012 by Children's Hospital Boston
Sponsor:
Collaborator:
Boston Brace
Information provided by (Responsible Party):
Michele DeGrazia, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01218087
First received: September 30, 2010
Last updated: August 30, 2012
Last verified: August 2012
History of Changes
  Purpose

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 z-flo device, or to a cranial cup device and z-flo 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.


Condition Intervention
Plagiocephaly
Scaphocephaly
Brachycephaly
 Device: cranial cup device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Cranial index measured at hospital discharge [ Time Frame: up to 120 days ] [ Designated as safety issue: No ]
    hospital discharge will vary with each subject (up to 120 days)

  • Cranial symmetry measured at hospital discharge [ Time Frame: up to 120 days ] [ Designated as safety issue: No ]
    Outcome measure obtained at hospital discharge (up to 120 days).


Secondary Outcome Measures:
  • Incidence of apnea events [ Time Frame: daily up to 120 days ] [ Designated as safety issue: Yes ]
    daily log of desaturation events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside


Estimated Enrollment: 160
Study Start Date: April 2010
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cranial cup plus Z-flo device
Alternating use of cranial cup and Z-flo device over a 24 hour period
 Device: cranial cup device
device used to prevent head shape deformity in the infant
Active Comparator: Z-flo device Device: cranial cup device
device used to prevent head shape deformity in the infant

Detailed Description:

The primary outcome for this study will be cranial index and cranial symmetry measured at hospital discharge; the secondary outcome measure is the incidence of oxygen desaturation events (apnea, bradycardia and oxygen desaturation).

The pilot study was undertaken to evaluate if the cranial cup can be successfully incorporated into the NICU patient care regime, the pilot study included 5 infants.

The main trial enrollment is 160 infants from 3 centers. Upon enrollment infants will be randomized to one of two study groups

  • Cranial cup and Z flo
  • Z flo Infants will be stratified by study site and weight at enrollment (< 1000 grams versus = / > 1000 grams).

Inclusion criteria:

There are several inclusion criteria for participation in the study:

  1. Infants born at >/= 22 weeks gestation
  2. Infant that are </= 7 days of age
  3. Infants that receive medical clearance from their healthcare team
  4. Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment
  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Infants born at >/= 22 weeks gestation
  2. Infant that are </= 7 days of age
  3. Infants that receive medical clearance from their healthcare team
  4. Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment

Exclusion Criteria:

  1. 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
  2. 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
  3. Infants with a craniofacial anomaly, cervical anomaly, or critical airway infants
  4. Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the cranial cup may worsen a preexisting condition
  5. Infants with a prenatal diagnosis of craniosynostosis
  6. Infants deemed not suitable for participation by the attending neonatologist
  7. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218087

Contacts
Contact: Michele DeGrazia, PhD, NNP 617-355-8087 michele.degrazia@childrens.harvard.edu

Locations
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Michele DeGrazia, PhD, NNP     617-355-8078     michele.degrazia@childrens.harvard.edu    
Sponsors and Collaborators
Children's Hospital Boston
Boston Brace
Investigators
Principal Investigator: Michele DeGrazia, PhD, NNP Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Michele DeGrazia, Director Nursing Research, NICU, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01218087     History of Changes
Other Study ID Numbers: 08120584
Study First Received: September 30, 2010
Last Updated: August 30, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Positional Head Shape Deformity

Additional relevant MeSH terms:
Congenital Abnormalities
Craniosynostoses
Plagiocephaly
Synostosis
Dysostoses
 Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities

ClinicalTrials.gov processed this record on May 16, 2013