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

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.

Study Overview

• Status: Terminated
• Conditions: Plagiocephaly; Brachycephaly; Scaphocephaly
• Intervention / Treatment: Device: Cranial cup device and Moldable positioner; Device: Moldable positioner device

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 </= 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

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

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cranial cup device and Moldable positioner device; The cranial cup for 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours	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.
Active Comparator: Moldable positioner device; Moldable positioner device was used for positioning infants for 24/24 hours	Device: Moldable positioner device; This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Cardiorespiratory	daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside	daily up to 120 days

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Boston Orthotics & Prosthetics

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: September 30, 2010
• First Submitted That Met QC Criteria: October 7, 2010
• First Posted (Estimate): October 11, 2010

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Positional Head Shape Deformity
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Congenital Abnormalities; Plagiocephaly; Craniosynostoses
• Other Study ID Numbers: 08120584