Dolichocephaly
Conditions
Brief summary
The purpose of this descriptive study is to provide information on the feasibility of using the cranial cup, a new positioning device, in a small sample of prematurely born infants with elongated head shapes as a result of laying on their abdomens, during the convalescent phase of their hospitalizations.
Detailed description
The cranial cup is a non-invasive, non-restrictive, adjustable orthotic device that grows with the infant and maintains proper body alignment while promoting normal head shape development. While the cranial cup is not yet FDA approved, it is considered a non-significant medical device and it has successfully corrected asymmetric positional head shape deformities in hundreds of healthy newborns less than 4 months of age cared for by the Children's Hospital Boston outpatient plagiocephaly clinic. Additionally preliminary analysis of a prospective randomized controlled trial currently underway suggests that the cranial cup may be useful in prevention of positional head shape deformity in a cohort of hospitalized infants of varying gestational ages. However, the cranial cup has never been used for correction of the most common form of positional head shape deformity in hospitalized premature infants; namely dolichocephaly. Thus, the purpose of this descriptive study is to provide information on the feasibility of using the cranial cup in a small sample of prematurely born infants with dolichocephaly during the convalescent phase of their hospitalizations. Information obtained from this descriptive study will be used to determine if a larger investigation using the cranial cup is warranted in this specific patient population.
Interventions
DEVICECranial Cup
Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* Born at \< or equal to 35 weeks gestation * Cleared for participation by healthcare team * Estimated minimum length of stay \>14 days * Weight \>1000 grams (at enrollment) * Dolichocephalic head shape deformity
Exclusion criteria
* Unable to maintain airway patency (anatomical problem) * Craniofacial anomaly or scalp device, drain or shunt * Craniosynostosis * Severe parturitional head shape deformity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Safety | Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days | Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of \< 90 percent for infant corrected to full term or \< 87 percent for a premature infant for \> 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cranial Measurement Description | Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days) | To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cranial Cup Arm Single arm
Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Cranial Cup Arm |
|---|---|
| Age, Continuous | 34.6 weeks |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Feasibility and Safety
Nurses will complete daily logs indicating the number of desaturation events (oxygen saturation of \< 90 percent for infant corrected to full term or \< 87 percent for a premature infant for \> 10 seconds) and emesis events (regurgitation of breast milk or formula) during cranial cup device use. The cup's designated use is for at least 12 hours per day. Study duration is at least 14 days and can continue until the infant is discharged. Comparisons will be made for the number of desaturation events and emesis during data analysis.
Time frame: Logs of cranial cup use and desaturation and emesis events will be recorded for 14 -120 days
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cranial Cup Arm | Feasibility and Safety | desaturation events | 7 count |
| Cranial Cup Arm | Feasibility and Safety | emesis events | 1 count |
Secondary
Cranial Measurement Description
To describe infant head shape, the study will use cranial measurements and laser head scans in a sample of prematurely born Neonatal Intensive Care (NICU) or Special Care Nursery (SCN) patients with dolichocephaly. Cranial measurement used is cranial index, an objective measure that quantifies head shape by dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Measurements and scans will be taken directly following study enrollment and discharge to document head shape pre and post intervention. The discharge measure will be obtained at approximately 2 weeks-4 months of age at hospital discharge.
Time frame: Using head measurements obtained at timepoint 1 enrollment (baseline, day 1) and at timepoint 2 discharge (14-120 days)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cranial Cup Arm | Cranial Measurement Description | 77.5 cranial index % |