Brachycephaly, Plagiocephaly, Scaphocephaly
Conditions
Keywords
Positional Head Shape Deformity
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 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).
Interventions
DEVICECranial 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
DEVICEMoldable positioner device
This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.
Sponsors
Boston Orthotics & Prosthetics
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cranial Abnormalities Were Measured at Hospital Discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cardiorespiratory | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cranial Cup Device cranial cup 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 the infant | 27 |
| Moldable Positioner Device moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device. | 35 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 1 |
| Overall Study | Transferred | 8 | 5 |
| Overall Study | Withdrawal by Subject | 5 | 0 |
Baseline characteristics
| Characteristic | Cranial Cup Device | Moldable Positioner Device | Total |
|---|---|---|---|
| Age, Continuous | 0 days | 0 days | 0 days |
| Gender Female | 9 Participants | 13 Participants | 22 Participants |
| Gender Male | 18 Participants | 22 Participants | 40 Participants |
| Race/Ethnicity, Customized African American | 7 participants | 7 participants | 14 participants |
| Race/Ethnicity, Customized Asian | 1 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic | 4 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Native Hawaiian | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 15 participants | 26 participants | 41 participants |
| Region of Enrollment United States | 27 participants | 35 participants | 62 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 35 |
| serious Total, serious adverse events | 0 / 27 | 0 / 35 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cranial Cup Device | Cranial Abnormalities Were Measured at Hospital Discharge | 46 % participant cranial abnormalities |
| Moldable Positioner Device | Cranial Abnormalities Were Measured at Hospital Discharge | 19 % participant cranial abnormalities |
p-value: 0.03Fisher Exact
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cranial Cup Device | Incidence of Cardiorespiratory | 5.4 cardioresp. events/100hrs of device use |
| Moldable Positioner Device | Incidence of Cardiorespiratory | 5.9 cardioresp. events/100hrs of device use |