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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Boston Children’s Hospital

Current Primary Outcome: 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.


Original Primary Outcome:

  • 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) ]


Current Secondary Outcome: 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


Original Secondary Outcome: 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


Information By: Boston Children’s Hospital

Dates:
Date Received: September 30, 2010
Date Started: April 2010
Date Completion:
Last Updated: December 8, 2016
Last Verified: December 2016