- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00396838
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Haifa, Israel
- Rambam MC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- normal full-term newborns (>38 weeks)
- Apgar score >=8 at five minutes after delivery.
Exclusion Criteria:
- congenital anomalies
- medical complications
- need for oxygen administration
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Amir Weissman, MD, Rambam MC
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1909CTIL
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