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

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ClinicalTrials.gov Identifier: NCT01218087
Recruitment Status : Terminated (Study discontinued by DSMB due to loss of equipoise.)
First Posted : October 11, 2010
Results First Posted : August 26, 2015
Last Update Posted : February 3, 2017
Sponsor:
Collaborator:
Boston Brace
Information provided by (Responsible Party):
Michele DeGrazia, Boston Children’s Hospital

September 30, 2010
October 11, 2010
March 17, 2015
August 26, 2015
February 3, 2017
April 2010
July 2012   (Final data collection date for primary outcome measure)
Cranial Abnormalities Were Measured at Hospital Discharge [ Time Frame: up to 120 days ]
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.
  • Cranial index measured at hospital discharge [ Time Frame: hospital discharge (up to 120 days) ]
    hospital discharge will vary with each subject (up to 120 days)
  • Cranial symmetry measured at hospital discharge [ Time Frame: hospital discharge (up to 120 days) ]
Complete list of historical versions of study NCT01218087 on ClinicalTrials.gov Archive Site
Incidence of Cardiorespiratory [ Time Frame: daily up to 120 days ]
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Incidence of apnea events [ Time Frame: daily up to 120 days ]
daily log of desaturation events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Not Provided
Not Provided
 
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
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.

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).

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Plagiocephaly
  • Scaphocephaly
  • Brachycephaly
  • 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.
  • 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
    Interventions:
    • Device: Cranial cup device and Moldable positioner
    • Device: Moldable positioner device
  • Active Comparator: Moldable positioner device
    Moldable positioner device was used for positioning infants for 24/24 hours
    Intervention: Device: Moldable positioner device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
88
160
July 2012
July 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 10 Days   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01218087
08120584
No
Not Provided
Not Provided
Michele DeGrazia, Boston Children’s Hospital
Boston Children’s Hospital
Boston Brace
Principal Investigator: Michele DeGrazia, PhD, NNP Boston Children’s Hospital
Boston Children’s Hospital
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP