Clinical trial NCT01683812: Cranial Cup Use for Correction of Head Shape Deformities
Official title: Cranial Cup Use for the Correction of Positional Head Shape Deformities in Hospitalized Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dolichocephaly
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2012-09-12
Enrollment: 23
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.

Detailed description: The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows with the infant and maintains proper body alignment while promoting normal head shape development. While the cranial cup is not yet FDA approved, it is considered a non-significant medical device and it has successfully corrected asymmetric positional head shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis of a prospective randomized controlled trial currently underway suggests that the cranial cup may be useful in prevention of positional head shape deformity in a cohort of hospitalized infants of varying gestational ages. However, the cranial cup has never been used for correction of the most common form of positional head shape deformity in hospitalized premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to provide information on the feasibility of using the cranial cup in a small sample of prematurely born infants with dolichocephaly during the convalescent phase of their hospitalizations. Information obtained from this descriptive study will be used to determine if a larger investigation using the cranial cup is warranted in this specific patient population.

Eligibility criteria: Inclusion Criteria:

* Born at \< or equal to 35 weeks gestation
* Cleared for participation by healthcare team
* Estimated minimum length of stay \>14 days
* Weight \>1000 grams (at enrollment)
* Dolichocephalic head shape deformity

Exclusion Criteria:

* Unable to maintain airway patency (anatomical problem)
* Craniofacial anomaly or scalp device, drain or shunt
* Craniosynostosis
* Severe parturitional head shape deformity

Primary outcomes:
measure: Feasibility and Safety
timeFrame: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days
Secondary outcomes:
measure: Cranial Measurement Description
timeFrame: Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Winchester
country: United States
facility: Winchester Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Michele DeGrazia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Winchester Hospital
name: Aimee Knorr, MD
role: PRINCIPAL_INVESTIGATOR
References: