NCT00740298

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
178

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable pain

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

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2008

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2018

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

9.8 years

First QC Date

August 20, 2008

Last Update Submit

April 24, 2023

Conditions

Pain

Keywords

infantsundergoingvaccinations

Outcome Measures

Primary Outcomes (1)

  • Decreased behavioral and physiologic indicators of pain

    5 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

Sweet Taste

Other: sucrose

2

ACTIVE COMPARATOR

warmth

Other: warmth

Interventions

sucroseOTHER

sweet taste

1
warmthOTHER

warmth

2

Eligibility Criteria

AgeUp to 2 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy infants

You may not qualify if:

  • unhealthy infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Lawrence A Gray, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2008

First Posted

August 22, 2008

Study Start

July 1, 2008

Primary Completion

April 26, 2018

Study Completion

April 26, 2018

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations

US(1)