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Clinical Policy Bulletin:
Car-Ride Simulators for Infantile Colic
Number: 0523


Policy

Aetna considers car-ride simulators (e.g., SleepTight Infant Soother) experimental and investigational because their effectiveness has not been established. 

Note: Car-ride simulators for infantile colic do not meet Aetna’s definition of covered durable medical equipment because they are not primarily medical devices, and they are of use in the absence of illness or injury, (i.e., promoting sleep).



Background

Infantile colic is a common problem among babies in their first months of life.  Despite many years of investigation, the cause of this frustrating problem for parents and caregivers alike is still unclear.  Crying usually occurs in the evenings; episodes commencing in the first weeks of life and ending at the age of 4 to 5 months.  Over the years, many approaches ranging from pharmacotherapy to behavioral methods have been used to manage infantile colic; however no effective cure has been demonstrated for this disorder.

Currently, the mainstays of treatment of this time-limited problem entail parental reassurance and behavioral management.  Dietary changes (soy formula), herbal tea, and reduction of stimulation level in the infant's environment have been tried with varying degrees of success.

Car-ride simulators (e.g., SleepTight Infant Soother, Sweet Dreams, Inc., Westerville, OH) have also been used to treat infantile colic.  These devices attempt to soothe crying, fussy and colicky babies by vibrating the infant's crib to simulate the sound and motion of a car traveling at 55 miles per hour.  Published studies, including a randomized controlled trial (RCT), do not establish the effectiveness of this device; they were no better than caregiver reassurance and support alone in decreasing daily hours of crying and maternal anxiety.

An assessment of interventions for infantile colic concluded that car-ride simulators are of “unknown effectiveness” (Lucassen, 2009).  The assessment noted that, use of a crib vibrator device may be no more effective than reassurance, focused advice, and/or infant massage at reducing the duration of crying.

In a systematic review, Perry et al (2011) evaluated all RCTs of nutritional supplements and other complementary and alternative medicines as a treatment for infantile colic.  Five electronic databases were searched from their inception to February 2010 to identify all relevant RCTs of complementary and alternative medicines and supplements for infantile colic.  Reference lists of retrieved articles were hand searched.  Data were extracted by 2 independent reviewers, and methodological quality was assessed using the Jadad score and key aspects of the Cochrane risk of bias.  A total fo 15 RCTs met the inclusion criteria and were included -- 13 studies were placebo-controlled; 8 were of good methodological quality; 11 trials indicated a significant result in favor of complementary and alternative medicines.  However, none of these RCTs was without flaws.  Independent replications were missing for most modalities.  The authors concluded that some encouraging results exist for fennel extract, mixed herbal tea, and sugar solutions, although it has to be stressed that all trials have major limitations.  Thus, the notion that any form of complementary and alternative medicine is effective for infantile colic currently is not supported from the evidence from the included RCTs.  The authors concluded that additional replications are needed before firm conclusions can be drawn.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There are no specific codes for car-ride simulators:
ICD-9 codes not covered for indications listed in the CPB: (not all-inclusive):
789.00 - 789.09 Abdominal pain (infantile colic)


The above policy is based on the following references:
  1. Garrison MM, Christakis DA. A systematic review of treatments for infant colic. Pediatrics. 2000;106:184-190.
  2. Huhtala V, Lehtonen L, Heinonen R, Korvenranta H. Infant massage compared with crib vibrator in the treatment of colicky infants. Pediatrics. 2000;105(6):E84.
  3. Lucassen PL, Assendelft WJ, Gubbels JW, et al. Effectiveness of treatments for infantile colic: Systematic review. Br Med J. 1998;316(7144):1563-1569.
  4. Balon AJ. Management of infantile colic. Am Fam Physician. 1997;55(1):235-242, 245-246.
  5. Parkin PC, Schwartz CJ, Manuel BA. Randomized controlled trials of three interventions in the management of persistent crying of infancy. Pediatrics. 1993;92(2):197-201.
  6. Sosland JM, Christophersen ER. Does SleepTight work? A behavioral analysis of the effectiveness of SleepTight for the management of infant colic. J Appl Behav Anal. 1991;24(1):161-166.
  7. Barr RG. Crying and colic. In: Rudolph’s Pediatrics. 20th ed. AM Rudolph, ed. Stamford, CT: Appleton & Lange; 1996:98-100.
  8. Leung AK, Lemay JF. Infantile colic: A review. J R Soc Health. 2004;124(4):162-166.
  9. Roberts DM, Ostapchuk M, O'Brien JG. Infantile colic. Am Fam Physician. 2004;70(4):735-740.
  10. Rogovik AL, Goldman RD. Treating infants' colic. Can Fam Physician. 2005;51:1209-1211.
  11. Lucassen P. Infantile colic. In: BMJ Clinical Evidence. London, UK: BMJ Publishing Group; updated September 2009.
  12. Crotteau CA, Wright ST, Eglash A. Clinical inquiries. What is the best treatment for infants with colic? J Fam Pract. 2006;55(7):634-636.
  13. Perry R, Hunt K, Ernst E. Nutritional supplements and other complementary medicines for infantile colic: A systematic review. Pediatrics. 2011;127(4):720-733.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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