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Prevention of deformational plagiocephaly in hospitalized infants using a new orthotic device
Insights
A cranial cup device, used with a moldable positioner, is a safe and effective therapy for preventing deformational plagiocephaly in hospitalized infants. This combination therapy significantly reduced abnormal cranial measurements at discharge.
Area of Science:
- Pediatric care
- Neonatal health
- Cranial orthotics
Background:
- Deformational plagiocephaly (DP) is a common condition in infants.
- Hospitalized infants, particularly those in neonatal intensive care units (NICUs), are at increased risk for DP.
- Early intervention is crucial for managing DP and preventing long-term complications.
Purpose of the Study:
- To evaluate the feasibility, safety, and efficacy of a cranial cup device for preventing DP in hospitalized infants.
- To compare the outcomes of using a moldable positioner alone versus a combination of a moldable positioner and cranial cup.
- To assess the impact of the cranial cup device on cranial measurements at discharge.
Main Methods:
- A multisite, randomized, single-blinded study involving 62 hospitalized infants at risk for DP.
- Infants were assigned to two groups: one using a moldable positioner, the other using a combination of a moldable positioner and cranial cup for 12 hours/day.
- Feasibility (hours of device use), safety (cardiorespiratory events, emesis), and efficacy (cranial measurements) were assessed.
Main Results:
- The cranial cup device was used for a median of 10.7 hours/day, demonstrating feasibility.
- No significant differences in cardiorespiratory or emesis events were observed between the devices.
- Significantly fewer infants in the cranial cup group (19%) had abnormal cranial measurements at discharge compared to the control group (46%) (p = .03).
Conclusions:
- The combination of a cranial cup and moldable positioner is a feasible, safe, and potentially effective therapy for preventing DP in hospitalized infants.
- This treatment approach shows promise in improving cranial symmetry and reducing the incidence of abnormal head shapes.
- Further research may support the routine use of this combined therapy in at-risk infant populations.
Objective:
To measure the feasibility, safety, and efficacy of the cranial cup device in a sample of hospitalized infants at risk for deformational plagiocephaly (DP).
Design:
A multisite, stratified, and randomized single-blinded study.
Setting:
Neonatal intensive care units (NICU) from three urban and one suburban hospital participated.
Participants:
Subjects included 62 infants with lengths of stay ≥ 14 days.
Methods:
Nurses caring for infants in study group 1 used the moldable positioner. In study group 2, nurses rotated the moldable positioner and cranial cup devices using the cranial cup for a target goal of 12 hours/day. Both study groups received routine position changes. Outcome measures included hours of device use (feasibility), cardiorespiratory and emesis events (safety), and cranial measurements obtained at discharge (efficacy) by one of four, licensed orthotists who were blinded to the study.
Results:
A total of 35 infants were randomized to study group 1 (moldable positioner) and 27 infants to study group 2 (moldable positioner and cranial cup). The median hours per day on the cranial cup was 10.7 (range 4.5-15.3). Emesis and cardiorespiratory events were equally distributed for the moldable positioner and cranial cup devices in study group 2. At discharge, more infants in study group 1 (46%, n = 16) exhibited abnormal cranial measurements than those in study group 2 (19%, n = 5) (p = .03).
Conclusion:
Rotating the cranial cup with the moldable positioner provides a feasible, safe, and potentially efficacious therapy for prevention of DP.
