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| Sponsored by: |
Rambam Health Care Campus |
| Information provided by: | Rambam Health Care Campus |
| ClinicalTrials.gov Identifier: | NCT00396838 |
Purpose
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.
| Condition |
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Pain |
| Study Type: | Observational |
| Study Design: | Prospective |
| Official Title: | Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates |
Eligibility
| Ages Eligible for Study: | up to 72 Hours |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations More Information
| Study ID Numbers: | 1909CTIL |
| First Received: | November 7, 2006 |
| Last Updated: | October 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00396838 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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