Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates

This study has been completed.
Sponsor:
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00396838
First received: November 7, 2006
Last updated: October 11, 2008
Last verified: March 2008
  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
Pain

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates

Further study details as provided by Rambam Health Care Campus:

Estimated Enrollment: 300
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00396838

Locations
Israel
Rambam MC
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Study Director: Amir Weissman, MD Rambam MC
  More Information

No publications provided by Rambam Health Care Campus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396838     History of Changes
Other Study ID Numbers: 1909CTIL
Study First Received: November 7, 2006
Last Updated: October 11, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on October 23, 2014