Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Background: Heel lancing is a routine procedure for the diagnosis of phenylketonuria in infants. Despite the short- and long-term adverse effects of pain, there are no guidelines for the reduction of such pain. Previous studies evaluated different treatment modalities; however, in most of them, pain response was assessed by subjective measures.
Aims of study: 1. To characterize the pain response of infants by using a computerized analysis of the ECG. 2. To compare six different methods of pain reduction during heel lancing in newborns.
Methods: The time, geometric and frequency domains of the infants' ECG will be computed during heel lancing. 150 healthy full-term infants will be evaluated in six treatment groups: breastfeeding, bottle feeding, skin-to-skin contact, lying on a table without anything, lying with a pacifier and lying while getting a glucose solution. The differences in pain response to these six treatment modalities will be assessed and compared to the infants' length of cry, and scoring of the infants' behavioral response.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396838
|Study Director:||Amir Weissman, MD||Rambam MC|