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ClevaFoam®

Researched and developed with the world renowned University at Trinity College in Dublin, ClevaFoam® is scientifically proven to significantly reduce the risk of your baby developing Plagiocephaly  also known as Flat Head Syndrome common in young babies. 

What is Plagiocephaly?

Deformational Plagiocephaly (DP), a medical condition more commonly known as ‘flat head syndrome’ (FHS), which occurs when an infant’s head becomes flatten and or misshaped due to the head continually resting on a surface that does not conform or support the shape of a baby’s head.   Infant heads are soft to allow for the initial passage through the birth canal and then the incredible brain growth that occurs in the first year of life.  During the early months of life they are more susceptible to being "molded" into a flat shape or taking the form of the surface that the skull is in contact with. 

Plagiocephaly  develops when an infant’s rapidly growing head attempts to expand, and meets some type of resistance— either prenatally in the mother’s womb, or more commonly after delivery because the back or side of a baby’s head is pressed against a mattress, car seat or other flat surface. 

This condition affects many infants, especially since the widespread introduction of the “Back to Sleep” campaign which recommends that babies are placed to sleep on their back (supine sleep)  that was introduced in 1994 and has made significant inroads to reducing the number of SID’s (Cot Deaths) by an estimated 46% in some countries.  However, the by-product of the supine sleeping is a significant increase of FHS which is now at epidemic proportions according the AAP (American Academy of Pediatrics) affecting nearly 50% of all baby by the age of 2 moments. (www.aap.org, 2013)

Babies suffering from Torticollis are also at risk of developing FHS due the nature of the condition which is a tight or shortened muscle in one side of the neck causes the head to tilt or turn to one side, resulting in the infant resting its head in the same position. 

A report issued by the AAP looked at the long term developmental outcomes in infants with FHS.  More evidence is emerging but it has long since been acknowledged by the medical profession that the affects of FHS are not limited to aesthetics. 

Infants with FHS comprise of a high-risk group for development difficulties presenting as subtle problems during the school-age years.  Many studies have indicated other issues include the Miller and Clarren report (Robert I Miller) that showed 39.37% of patients with FHS required an individual education plan.  In a report issued in the Journal of Developmental & Behavioural Pediatrics on Neurodevelopmental  Implications of “Deformational” Plagiocephaly  show that 33% of patients displayed mild to significant mental developmental issues when measure against the  MDI (Mental Developmental Index - BSID- III).   Further studies indicate that before any intervention, infants with deformational plagiocephaly show significant delays in both mental and psychomotor development. Also of particular note is that no child with deformational plagiocephaly showed accelerated development. (Kordestani, 2006)

Change to the Treatment of DP

In recent years the use of orthotic helmets have been used to correct the symmetry of infants heads and increasingly surgery has been conducted.   A recent study published in the British Medical Journal into the use of orthotic helmets and bands used by infants from as young as 6 months and for up to 23 hours a day for a typical period of 3 months shows that these do not work and the therapy results is so insignificant and the use of them has been discourage. (BMJ , 2014).  In addition, the report also states that infant found them uncomfortable and parents found them difficult. 

A certain amount of prone positioning, or “tummy time,” while the infant is awake and being observed is recommended to help prevent the development plagiocephaly.  This will also facilitate development of the upper shoulder girdle strength necessary for timely attainment of certain motor milestones.   Avoidance of prolonged placement indoors in car safety seats and swings should be discouraged. 

Dr Genevieve Keating reports that “Children who have less interference to their nervous system have a better chance of making sense of their world and their place in it. They have a better opportunity to develop good motor patterns and balance, good emotional regulation and better learning strategies for the future.”  (Keating) .  

This is one of the main reason why Prof. Michael J Earley, a Craniofacial Surgeon from the Children’s University Hospital in Dublin has endorsed ClevaFoam® by saying  “Having worked with Trinity College on this product, I am all in favour of this device as craniofacial surgery is a last resort and prevention is better than cure.”

Headline Facts

  • A baby’s skull is made up of several sections of bone, connected by fibrous joints called sutures, that fuse later in life. During the first few months of a child’s life, the skull itself is soft and malleable.
  • Plagiocephaly occurs when an infant’s soft skull becomes flattened in one area, due to repeated pressure on that particular part of the head.
  • Many babies develop plagiocephaly by sleeping regularly in one position, or by spending extensive time sitting in the same position in a car seat or swing.
  • Plagiocephaly occurs more often in premature infants whose skulls are even more pliable than other babies. These babies may spend a great deal of time lying down as they receive treatment for other medical complications.
  • The medical profession now acknowledges that Plagiocephaly is not just aesthetic
  • ClevaFoam® is the only product scientifically proven to reduce the pressure on the back of your baby’s head by 50% and increase support by 80%, thereby helping to prevent Flat Head Syndrome.  
  • Designed with safety in mind, ClevaFoam® is lightweight and breathable with reduced heat retention, making it suitable for use with babies.

University of Trinity College Research

In collaboration with world renowned University at Trinity College in Dublin, ClevaMama® carried out a comprehensive study on Deformational Plagiocephaly or Flat Head Syndrome. This research led to the development of ClevaFoam®, the only non-invasive aid proven to help in the prevention and correction of Flat Head Syndrome.

Researchers at Trinity College Centre for Bioengineering conducted a biomechanical analysis of contact between an infant skull and different support materials during bed rest. ClevaFoam®  was found to reduce the pressure on an infant’s skull which aggravates flat head syndrome by up to 50% and increase support by 80%. The study found both lower stress distribution on a baby’s head and lower strain energy density when using ClevaFoam® products. 

Executive Summary of Report

Deformational plagiocephaly is a medical condition, common for infants, describing local flattening of regions of the skull due to persistent localised pressure. Incidence has risen dramatically since the advent of recommendations to place sleeping infants on their backs as a preventative measure against sudden infant death syndrome. Although several treatment options exist there is scope for utilisation of passive devices during the early weeks and months after birth when infants are more prone to development of the condition due to relatively low levels of activity.

A study was undertaken to investigate the use of a polyurethane foam pillow (specifically a ClevaMama® ClevaFoam®) as a means of reducing contact pressure to the occipital region of an infant skull during supine bed rest. Preliminary characterisations of (i) the ClevaFoam® used in the pillow and (ii) a generic infant mattress were carried out to define relevant support conditions for the desired analyses. A finite element model of an infant cranium was constructed, taking account of relevant structural features for the analysis of skull contact behavior. Simulations of the skull were performed for (i) normal bed rest on the generic mattress and (ii) resting on the ClevaFoam® pillow, which was in turn supported by the mattress from (i). The foam and mattress were successfully characterized for the purposes of the study.

Simulation of the two bed rest cases predicted that use of ClevaFoam® would reduce the mean contact pressure in the occipital region by increasing contact area and conformity. Furthermore, local tissue loading was also predicted to decrease with the use of ClevaFoam®. Predictions of the study were within range of values reported in the literature.

In conclusion, simulations of supine rest of an infant cranium in contact with (i) a generic infant mattress and (ii) a ClevaMama® ClevaFoam® Baby Pillow supported a hypothesis that use of the ClevaFoam® can reduce mean contact pressure at the occiput by increasing contact area through greater conformant deformation.

Results

Analysis of the deformation of each model (Fig. 13) shows that the ClevaFoam® model deformed more than the stiffer case of only the mattress. Furthermore, greater contact area between the cranium and its support was predicted for ClevaFoam® support condition (Fig. 14) — 2,959 mm2 for the mattress and 5,644 mm2 for the pillow. This increase in contact area for the pillow support leads to a reduction in the contact pressure (i.e. the contact force per unit area) since the force (i.e. the gravitational load, which was 8.55 N) is the same for each model. Thus the mattress support was predicted to apply an average contact pressure of 2.9 kPa to the skull while the pillow applied an average pressure of 1.5 kPa.

A benefit of using the finite element method is the ability to predict internal loading and deformation of the tissues. Two measures of loading were examined for the two models: von Mises stress (indicative of the forces generated within the tissue) and strain energy density (indicative of the energy of deformation). Contours of stress (Fig. 15) show that stress was not distributed uniformly within the contact region. Local concentrations were predicted around the suture regions for both models. In particular local stress in these regions was up to an order of magnitude higher than the man contact pressure. Furthermore, a larger region of highly loaded tissue was predicted for the occipital region of the mattress support. This trend was more pronounced when examining the strain energy density of the exterior cranial tissue (Fig. 16). Both stress and strain-energy density were more localized to the sutures for the pillow support condition. In general, stresses were relatively low (< 25 kPa) in the occipital region of both models.

Conclusions

In conclusion, simulations of supine rest of an infant cranium in contact with two different supporting materials, (i) a generic infant mattress and (ii) a ClevaFoam®, supported a hypothesis that use of the compliant polyurethane foam can reduce mean contact pressure at the occiput by increasing contact area through greater conformant deformation. This study represents a first step in determining the local mechanical environment in the tissue of the contact region for an infant head resting in a supine position. The ability to study this mechanical environment opens the possibility of further study of the role of mechanical loading in the development of deformational plagiocephaly.

Cranio-Facial Specialist Prof. Michael Earley said of ClevaFoam®, “Having worked with Trinity College on this product, I am all in favour of this device as craniofacial surgery is a last resort and prevention is better than cure.”

Commenting on the research findings, Fellow Alexander Lennon from Trinity College said;

“There has been little study so far into the biomechanics that cause deformational plagiocephaly. We believe this research is an important step and goes a long way to advancing our understanding of potential mechanisms and treatments for Flat Head Syndrome”

Specifically engineered, designed and manufactured for babies, ClevaFoam® is breathable and employs AirFlow™ technology which draws moisture away from your baby and increases air flow.

The ClevaFoam® range works on two levels. Firstly, it is a scientifically proven preventative measure against Flat Head Syndrome. Secondly, it is a luxurious line of high quality nursery bedding. Our ClevaFoam® range includes pillows, mattresses, sleep positioners, head supports and play mats. For more information on these items see our product pages.

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