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

NCT01218087 | Terminated Results

• 1 other identifier: 08120584
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Plagiocephaly; Scaphocephaly; Brachycephaly

Keywords

Positional Head Shape Deformity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence of Cardiorespiratory

  daily up to 120 days

Study Arms (2)

Cranial cup device and Moldable positioner device

EXPERIMENTAL

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; Device: Moldable positioner device

Moldable positioner device

ACTIVE COMPARATOR

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

Device: Moldable positioner device

Interventions

Cranial cup device and Moldable positioner DEVICE

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

Cranial cup device and Moldable positioner device

Moldable positioner device DEVICE

This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.

Cranial cup device and Moldable positioner device; Moldable positioner device

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Boston Orthotics & Prosthetics: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Plagiocephaly; Craniosynostoses

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases

Limitations and Caveats

During the second interim analysis, safety monitors recommended early closure due to loss of study equipoise. Clinical staff had been reporting observable differences in infant head shapes for the two study groups.

Results Point of Contact

• Title: Michele DeGrazia
• Organization: Boston Children's Hospital

michele.degrazia@childrens.harvard.edu

617-919-1222

Study Officials

• Michele DeGrazia, PhD, NNP

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Nursing Research, NICU

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 11, 2010
• Study Start: April 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 3, 2017
• Results First Posted: August 26, 2015

Record last verified: 2016-12

Locations

US (1)