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

Primary Purpose

Plagiocephaly, Scaphocephaly, Brachycephaly

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cranial cup device and Moldable positioner
Moldable positioner device
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Plagiocephaly focused on measuring Positional Head Shape Deformity

Eligibility Criteria

undefined - 10 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cranial cup device and Moldable positioner device

Moldable positioner device

Arm Description

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

Moldable positioner device was used for positioning infants for 24/24 hours

Outcomes

Primary Outcome Measures

Cranial Abnormalities Were Measured at Hospital Discharge
Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.

Secondary Outcome Measures

Incidence of Cardiorespiratory
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside

Full Information

First Posted
September 30, 2010
Last Updated
December 8, 2016
Sponsor
Boston Children's Hospital
Collaborators
Boston Orthotics & Prosthetics
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1. Study Identification

Unique Protocol Identification Number
NCT01218087
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study discontinued by DSMB due to loss of equipoise.
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
Collaborators
Boston Orthotics & Prosthetics

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plagiocephaly, Scaphocephaly, Brachycephaly
Keywords
Positional Head Shape Deformity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cranial cup device and Moldable positioner device
Arm Type
Experimental
Arm Description
The cranial cup for 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours
Arm Title
Moldable positioner device
Arm Type
Active Comparator
Arm Description
Moldable positioner device was used for positioning infants for 24/24 hours
Intervention Type
Device
Intervention Name(s)
Cranial cup device and Moldable positioner
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Moldable positioner device
Intervention Description
This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.
Primary Outcome Measure Information:
Title
Cranial Abnormalities Were Measured at Hospital Discharge
Description
Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.
Time Frame
up to 120 days
Secondary Outcome Measure Information:
Title
Incidence of Cardiorespiratory
Description
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Time Frame
daily up to 120 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele DeGrazia, PhD, NNP
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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