An interventional study of Cranial cup device and Moldable positioner and Moldable positioner device in Plagiocephaly, Scaphocephaly and Brachycephaly, sponsored by Boston Children's Hospital. Terminated at 1 site in United States. Open to participants aged Up to 10 Days. Per ClinicalTrials.gov, last updated 2017-02-03.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Prevention
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
Inclusion criteria:
There are several inclusion criteria for participation in the study:
Infants were stratified by study site and weight at enrollment (\< 1000 grams versus = / > 1000 grams).
16 studies on the registry are indexed under Plagiocephaly; 4 are open to participants now.
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Exclusion Criteria:
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 was used for positioning infants for 24/24 hours
Device: 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
This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.
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.
Time frame: up to 120 days
Incidence of Cardiorespiratory
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Time frame: daily up to 120 days
| Milestone | Cranial Cup Device | Moldable Positioner Device |
|---|---|---|
| Started | 42 | 41 |
| Completed | 27 | 35 |
| Not completed | 15 | 6 |
| Withdrew: Death | 2 | 1 |
| Withdrew: Withdrawal by subject | 5 | 0 |
| Withdrew: Transferred | 8 | 5 |
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.
| % participant cranial abnormalities | Cranial Cup Device | Moldable Positioner Device |
|---|---|---|
| Cranial Abnormalities Were Measured at Hospital Discharge | 46 | 19 |
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
| cardioresp. events/100hrs of device use | Cranial Cup Device | Moldable Positioner Device |
|---|---|---|
| Incidence of Cardiorespiratory | 5.4 | 5.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cranial Cup Device | — | 0/27 (0%) | 0/27 (0%) |
| Moldable Positioner Device | — | 0/35 (0%) | 0/35 (0%) |
Approximately 800 infants from the 4 participating NICUs were screened; most were excluded for an anticipated length of stay of \< 14 days, for medical reasons, and a few parents declined. The total number enrolled out of the approximately 800 screened was 88.
| Age, Continuous(days) | Cranial Cup Device | Moldable Positioner Device | Total |
|---|---|---|---|
| Median | 0 (0 to 7) | 0 (0 to 12) | 0 (0 to 12) |
| Gender(Participants) | Cranial Cup Device | Moldable Positioner Device | Total |
|---|---|---|---|
| Female | 9 | 13 | 22 |
| Male | 18 | 22 | 40 |
| Race/Ethnicity, Customized(participants) | Cranial Cup Device | Moldable Positioner Device | Total |
|---|---|---|---|
| White | 15 | 26 | 41 |
| African American | 7 | 7 | 14 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian | 0 | 1 | 1 |
| Hispanic | 4 | 1 | 5 |
| Region of Enrollment(participants) | Cranial Cup Device | Moldable Positioner Device | Total |
|---|---|---|---|
| United States | 27 | 35 | 62 |
This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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