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.

Scope of Policy

This Clinical Policy Bulletin addresses car-ride simulators for infantile colic.

Experimental and Investigational

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

Policy Limitations and Exclusions

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).