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Thermal Analgesia in Newborns

NCT ID: NCT00740298

Last Updated: 2023-04-26

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

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-01

Study Completion Date

2018-04-26

Brief Summary

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Newborns routinely experience pain associated with invasive procedures such as blood sampling, immunization, vitamin K injection, or circumcision. Prevention of pain is both an ethical expectation and a professional imperative, as untreated pain has deleterious consequences including altered pain sensitivity in later childhood and may be related to the permanent neuroanatomical and behavioral abnormalities as found in animal models. Moreover, pain is a source of concern and distress for new parents. Yet, pain reducing therapies are often underused for the numerous minor procedures that are a part of routine medical and nursing care for neonates. Growing scientific and clinical literature provides evidence for the effectiveness of natural, non-pharmacological techniques in both animal and human newborns. This study compares the pain reliving effects of sweet taste to the combination of sweet taste and warmth.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Sweet Taste

Group Type ACTIVE_COMPARATOR

sucrose

Intervention Type OTHER

sweet taste

2

warmth

Group Type ACTIVE_COMPARATOR

warmth

Intervention Type OTHER

warmth

Interventions

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sucrose

sweet taste

Intervention Type OTHER

warmth

warmth

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* healthy infants

Exclusion Criteria

* unhealthy infants
Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lawrence A Gray, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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The University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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5K23HD049452

Identifier Type: NIH

Identifier Source: secondary_id

View Link

15480A

Identifier Type: -

Identifier Source: org_study_id

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