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

This study has been terminated.
(Study discontinued by DSMB due to loss of equipoise.)
Sponsor:
Collaborator:
Boston Brace
Information provided by (Responsible Party):
Michele DeGrazia, Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01218087
First received: September 30, 2010
Last updated: July 29, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Plagiocephaly
Scaphocephaly
Brachycephaly
Device: Cranial cup device and Moldable positioner
Device: Moldable positioner device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Cranial Abnormalities Were Measured at Hospital Discharge [ Time Frame: up to 120 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: daily up to 120 days ] [ Designated as safety issue: Yes ]
    daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside


Enrollment: 88
Study Start Date: April 2010
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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).

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218087

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Boston Brace
Investigators
Principal Investigator: Michele DeGrazia, PhD, NNP Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Michele DeGrazia, Director Nursing Research, NICU, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01218087     History of Changes
Other Study ID Numbers: 08120584
Study First Received: September 30, 2010
Results First Received: March 17, 2015
Last Updated: July 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Positional Head Shape Deformity

Additional relevant MeSH terms:
Plagiocephaly
Congenital Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 02, 2015