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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00396838
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : October 15, 2008
Sponsor:
Information provided by:

Study Description
Brief Summary:

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 or disease
Pain

Study Design

Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
Study Start Date : November 2006
Primary Completion Date : April 2008
Study Completion Date : April 2008
Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396838


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00396838     History of Changes
Other Study ID Numbers: 1909CTIL
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: October 15, 2008
Last Verified: March 2008