NCT00396838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

October 15, 2008

Status Verified

March 1, 2008

Enrollment Period

1.4 years

First QC Date

November 7, 2006

Last Update Submit

October 11, 2008

Conditions

Pain

Eligibility Criteria

Age48 Hours - 72 Hours
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • normal full-term newborns (\>38 weeks)
  • Apgar score \>=8 at five minutes after delivery.

You may not qualify if:

  • congenital anomalies
  • medical complications
  • need for oxygen administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam MC

Haifa, Israel

Location

Related Publications (1)

  • Weissman A, Aranovitch M, Blazer S, Zimmer EZ. Heel-lancing in newborns: behavioral and spectral analysis assessment of pain control methods. Pediatrics. 2009 Nov;124(5):e921-6. doi: 10.1542/peds.2009-0598. Epub 2009 Oct 19.

    PMID: 19841119DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amir Weissman, MD

    Rambam MC

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 8, 2006

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

October 15, 2008

Record last verified: 2008-03

Locations

IL(1)