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

NCT ID: NCT00396838

Last Updated: 2008-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

48 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role lead

Principal Investigators

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Amir Weissman, MD

Role: STUDY_DIRECTOR

Rambam MC

Locations

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Rambam MC

Haifa, , Israel

Site Status

Countries

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Israel

References

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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.

Reference Type DERIVED
PMID: 19841119 (View on PubMed)

Other Identifiers

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1909CTIL

Identifier Type: -

Identifier Source: org_study_id