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

Brief Title

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

Official Title

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

Brief 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.
    

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 was estimated to be 160 infants from 4 centers. Upon enrollment
      infants will be randomized to one of two study groups

        -  Cranial cup and moldable positioner

        -  Moldable positioner

      Inclusion criteria:

      There are several inclusion criteria for participation in the study:

        1. Infants born at >/= 22 weeks gestation

        2. Infant that are  14 days from the time
           of enrollment

      Infants were stratified by study site and weight at enrollment (< 1000 grams versus = / >
      1000 grams).
    


Study Type

Interventional


Primary Outcome

Cranial Abnormalities Were Measured at Hospital Discharge

Secondary Outcome

 Incidence of Cardiorespiratory

Condition

Plagiocephaly

Intervention

Cranial cup device and Moldable positioner

Study Arms / Comparison Groups

 Cranial cup device and Moldable positioner device
Description:  The cranial cup for 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

88

Start Date

April 2010

Completion Date

July 2012

Primary Completion Date

July 2012

Eligibility Criteria

        Inclusion Criteria:

          1. Infants born at >/= 22 weeks gestation

          2. Infant that are  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
      

Gender

All

Ages

N/A - 10 Days

Accepts Healthy Volunteers

No

Contacts

Michele DeGrazia, PhD, NNP, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01218087

Organization ID

08120584


Responsible Party

Principal Investigator

Study Sponsor

Boston Children's Hospital

Collaborators

 Boston Orthotics & Prosthetics

Study Sponsor

Michele DeGrazia, PhD, NNP, Principal Investigator, Boston Children's Hospital


Verification Date

December 2016