Pain Reactivity to Non-pharmacological Interventions Across Repeated Routine Heel-Sticks in Preterm Infants in a Neonatal Intensive Care Unit

Background and significance:

Switzerland with its approximately 8% of premature births is having one of the highest premature rates in Europe and most of the preterm neonates need neonatal intensive care. Recur-rent neonatal pain and stress occur routinely during neonatal intensive care, particularly among the extremely low birth weight preterm neonates . It has become clear in recent years that the nervous system undergoes extensive development postnatally and there is increasing evidence that repeated exposure to pain, may lead to serious biobehavioral changes during the sensitive developmental phase of the central nervous system and that these changes may underlie long-term learning and behavior difficulties in this patient population. The frequency of exposure to pain and the adequate treatment of that pain are therefore important factors in later motor and cognitive development in preterm infants requiring intensive care. Pain treatment in infants is viewed as inadequate in the context of acute diagnostic and therapeutic procedures in the NICU. Up to 80% of the analgesic used in neonatal intensive care units (NICU) are either "off label used" or "non-licensed used". Secondary to significant side effects, associated with the use of analgesics drugs, health care providers are often reticence to administer these drugs in the NICU. As an alternative approach non-pharmacological interventions for pain prevention and relief are increasingly being recommended for the prevention and treatment of mild and moderate pain in this population. This type of intervention includes methods that involve reducing the sensitivity of the neonates during and after painful procedures, which have been shown to effectively reduce pain from minor procedures in neonates.

Although non-pharmacological interventions have been shown to be efficacious when tested during a single painful procedure there is a lack of evidence related to their efficacy after infants have being exposed to a high number of painful procedures and the accompanying chronic stress. To improve the clinical outcomes there is a critical need for accurate and efficient neonatal pain management for this highly vulnerable patient population.

Specific aims:

To determine the sample size needed for a larger randomized clinical trial (RCT) designed to compare the sustained impact of three non-pharmacological approaches on the pain reactivity of premature neo-nates in a NICU.