Treatment of Cranial Molding Deformities in Preterm Infants
Condition: Preterm Infants; Dolichocephaly; Positional Scaphocephaly
MeSH terms: Craniosynostoses; Premature Birth
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of the Tortle Midliner
      positioning system in prevention and/or treatment of dolichocephaly, which can develop in
      preterm infants during the hospital stay.

      Specific Aim: Determine if the use of the Tortle Midliner is a more effective prevention and
      treatment strategy for dolichocephaly than current standard of care intervention in the Duke
      Intensive Care Nursery (ICN).
    

Detailed description: 
      Dolichocephaly (or positional scaphocephaly) is defined as a boat-shaped or elongated
      anterior-posterior axis as a result of skull flattening during side-to-side head positioning
      of infants during hospitalization. This deformity often takes place in preterm infants <32
      weeks because the preferred position is sidelying or prone for improved ease of containment,
      decreased reflux episodes, and decreased apnea/bradycardia. Supine positioning with head in
      midline is recommended to decrease the occurrence of this deformity, but maintaining midline
      is difficult as a result of gravity and preterm hypotonia. Developmental positioning through
      use of special positioning aids and caregiver education are common interventions used to
      address dolichocephaly. Dolichocephaly may resolve prior to hospital discharge, but in some
      cases infants are discharged home with the deformity.

      Despite documentation of dolichocephaly in preterm infants for nearly three decades, few
      studies report how often it occurs or the rate of resolution with intervention. Prematurity
      appears to be the most common predetermining factor. Preterm infants may experience a limited
      variety of positions due to autonomic instability or critical respiratory status. These
      infants are often positioned in prone to improve oxygenation and decrease incidence of
      reflux. Furthermore, the preterm infant demonstrates proximal hypotonia, causing the head to
      fall to either side with gravity while in supine. Bilateral flattening of the lateral skull
      develops as a result of the weight of the head and the pressure of gravity.

      The correlation between low birth weight and head flattening has been established in the
      literature. Researchers suggested that the deformity was preventable with the use of air or
      water pillows. Limited emphasis was placed on body position (i.e. supine, sidelying, or
      prone) in these articles. Since this period of time, the use of positioning aids and
      developmental positioning has been used to decrease the occurrence of dolichocephaly during
      hospitalization. Despite these interventions, some infants have dolichocephaly at hospital
      discharge.

      The long-term consequences of dolichocephaly are not fully known, but it has been correlated
      with delayed reaching skills, tightness in the spinal extensors and scapular retractors, and
      development of motor asymmetries. Other long-term effects of dolichocephaly have been
      evaluated minimally. Elliman's study demonstrated comparable developmental quotients at age 3
      when comparing a preterm group to controls. Kitchen and colleagues reported no differences in
      IQ at a 7-year follow up. Mewes and colleagues, however, suggest that the shift in cortical
      structures, caused by dolichocephaly may affect the preterm brain, which continues to develop
      rapidly after birth. Since the American Academy of Pediatrics established the widely
      successful and influential "Back to Sleep Campaign" in 1992, many studies have established
      the relationship between prevalence and long-term neuro-developmental outcomes of preterm
      infants with plagiocephaly - asymmetric flattening of the skull due to head preference - but
      there are no studies that determine the long-term neuro-developmental outcomes of preterm
      infants with dolichocephaly. Increased time spent supine, coupled with the fact that nearly
      half of preterm infants leave the hospital with a head preference, calls for updated
      long-term study of the effect of dolichocephaly specifically on neuro-developmental outcomes.
    

Intervention name(s): Tortle Midliner
Intervention type(s): Device
Intervention description(s): The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention