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

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT00396838
Collaborator
(none)
300
Enrollment
1
Location
17
Duration (Months)
17.7
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    300 participants
    Time Perspective:
    Prospective
    Official Title:
    Cardiac Autonomic Reactivity and Behavioral Response to Pain in Full-Term Neonates
    Study Start Date :
    Nov 1, 2006
    Actual Primary Completion Date :
    Apr 1, 2008
    Actual Study Completion Date :
    Apr 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      48 Hours to 72 Hours
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Rambam MC Haifa Israel

      Sponsors and Collaborators

      • Rambam Health Care Campus

      Investigators

      • Study Director: Amir Weissman, MD, Rambam MC

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00396838
      Other Study ID Numbers:
      • 1909CTIL
      First Posted:
      Nov 8, 2006
      Last Update Posted:
      Oct 15, 2008
      Last Verified:
      Mar 1, 2008

      Study Results

      No Results Posted as of Oct 15, 2008