Head N Wedge™ Information and Research

Moro Reflex (Startle Reflex)- Infant extends their arms and legs away from the body and to the side and then draws them together as if in an embrace. This reflex typically disappears by month 5 or 6. This is typically when your baby is strong enough to roll over. It is good practice to start swaddling at birth and end it around 4-6 months. Swaddling helps recreate the womb environment, which can help soothe babies while experiencing this startle reflex. Consistently making swaddling part of your bedtime or nap time ritual early on will help create the association that, once the swaddle is on, it’s time for sleepHowever, there are babies that do not sleep as well in a swaddle blanket and, in these cases, their natural position is to leave arms in an upright position. The two wedge pieces give that extra barrier and cushion, and they help to keep their arms in the upright position until they are ready to bring their arms down. The headpiece gives that extra stability by keeping the infant’s neck stabilized because of the head insert. The headpiece is also attached to the body piece with a fastener for more stability. Infants start to self-soothe themselves to sleep around 3 months, and they sometimes shake their heads back and forth until they are asleep. When infants self-soothe, they should not be able to get the headpiece detached because it is attached to the wedge piece.
The Head N Wedge™ also provides that snug fit by stabilizing them on their back, and helps prevent them from rolling into an unsafe position such as on their side or on to their stomach. Once baby is learning to roll over, it is no longer safe to swaddle. This is also when the Head N Wedge low setting wedge piece that stands 2 inches tall should be removed from the crib. The headpiece may continue to be used until infant is 12 months old.

The headpiece is made with low-density very soft breathable 3D air mesh tencel fiber, which is 32% Lyocell and 68% polyester material and is machine washable. The sandwich honeycomb air mesh on the back of the headpiece and wedge piece is Hypoallergenic and Oeko-Tex-certified material that has been tested for hazardous chemicals and is Category 1 which is safe for babies and children. Oeko-Tex is a product testing system that labels and certifies the safety of textiles and textile products. This cool air vent system helps keep infant from overheating, and also soaks up any spit up immediately to help prevent any contents from being inhaled back into their lungs. The headpiece and head insert are filled with the sandwich honeycomb air mesh. The headpiece has an insert where the back of infant’s head “the occiput” is placed and has an opening to allow head growth, while not compressing the back of the head.

  • The 2 wedges also contain the same low-density, very soft, breathable 3D air mesh Tencel fiber. The wedges are also made with low-density, lightweight polyurethane foam.
  • The wedge piece outer cover is made with 100% cotton and 100% polyester and is very soft.
  • The entire piece is machine washable on delicates with like colors and tumble-dry low.

Warnings

  • ALWAYS place infants on their BACKS while in the device and on a firm mattress in the crib, bassinet, Pack N Play, or a safe place on the ground.
  • DO NOT place infant on their sides or stomachs while in device.
  • Never co-sleep with infant in device or out of device.
  • Keep both wedges fastened in place while infant is in device.
  • Keep household temperature at 68 to 72 degrees Fahrenheit to prevent overheating infant.
  • Keep infant in an upright position for short time after breastfeeding and bottle-feeding to help reduce spit up, before placing them in Head N Wedge™.
  • Place infant in footie pajamas, swaddle blanket, sleep sack, or may swaddle infant with swaddler.
  • No heavy blankets or loose objects should be in crib with infant.
  • Once infant can roll and readily move around, wedge piece should be removed permanently usually around 4 to 6 months of age.

For Hospital Use:

  • Parents should be taught how to use the Head N Wedge™ and have the packaging with instructions to go home with.
  • If infant is on an incline in the hospital cribs and supervised, Head N Wedge can help keep them from sliding down in an unsafe position.
  • If parents are unable to swaddle the infant snug, the Head N Wedge will help keep them stabilized on their backs and help prevent them from rolling to their sides or stomachs. The headpiece also provides more head and neck stability when their head is placed in head insert.
  • Preemie babies in the NICU or any baby that will have a longer stay at the hospital can also benefit from the Head N Wedge, because the headpiece stabilizes their head and neck and helps maintain a round head shape from birth. Wedge pieces can fold out in the hospital setting if infant is supervised and has IV, ECG leads in place, or any cords attached to that side of body. Head N Wedge can also be washed for reuse when they spit up or soil the device.
  • Positional Plagiocephaly (Flat Head Syndrome)- flatness to one side of the back of the head due to infant being placed on their back for long periods of time, or due to infant favoring one side to lay on, which is torticollis of the neck. Brachycephaly-flatness to the back of the head, can be caused from early closure of Coronal sutures, or from laying on their backs for long periods of time. Scaphocephaly is early closure/ premature fusion to the sagittal suture that runs from the front to the back at the top of the skull forcing the head to grow long and narrow. Infants have very soft, moldable heads that rapidly grow and quadruple in size by the time they are 2 years of age.
  • Posterior fontanelle closes by age 1 to 2 months, and anterior fontanelle closes sometime between 9 months and 18 months.
  • The number of children with flat head or positional plagiocephaly has risen significantly in recent years in part due to SIDS guidelines which began in 1992 with the SIDS Campaign, and recommended placing babies on their backs to sleep. The Head N Wedge can increase sleep cycles by keeping infant snug on their backs for safer sleep and helping infant maintain a round head shape from birth.
  • Flat head syndrome affects nearly 1 in every 2 babies approximately 47%, and 1 in every 4 babies may be severe enough to have a recommendation for helmet therapy. Rigorous Systematic Review examined the link between developmental delay and flat head, which affects 1 in every 4 babies. Study shows that positional plagiocephaly is associated with an increased risk of developmental delays, in particular motor skills.
  • The Review of 19 papers published in the Journal of Developmental and Behavioral Pediatrics found:
  • Delays in motor skills, language and cognition were detected in infants as young as six months old and remained for up to 3 years.
  • The most commonly reported delay was in motor skills-such as sitting up and crawling-followed by delays in language.
  • Supervised tummy time while awake and alternating the head position can help strengthen the neck muscles to reduce the risk of infant continually turning their neck to one side, which can cause torticollis and lead to a positional plagiocephaly.
  • Severe cases are often treated with an orthotic helmet (Doc Bands) from Cranial Technology. However, recent evidence shows these are not as effective as initially thought.
  • Reference: George Institute for Global Health. “Flat head syndrome linked to motor, language and cognitive delays.” ScienceDaily. ScienceDaily, 24 January 2017. www.sciencedaily.com/releases/2017/01/170124111344.htm
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