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The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU

NCT03745963 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2018-11-21

No results posted yet for this study

Summary

The aim of this study is to examine the effect of SSC compared to sucrose on pain induced activity in the preterm infant brain using: a) series of low intensity experimental stimuli (PinPrick);and b) medically required heel lance. Secondary objectives include determining: a) differences between behavioral pain response and pain response during heel lance; and b) rate of adverse events across groups.

Conditions

  • Pain, Acute
  • Infant, Newborn
  • Electroencephalography

Interventions

BEHAVIORAL

Skin-to-skin contact

Infants allocated to the SSC arm will be placed in upright, ventral SSC position (holding of a diaper clad baby on the bare chest of a mother) for a minimum of 15 minutes prior to data collection.

DRUG

24% oral sucrose

Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance.

Sponsors & Collaborators

  • Nova Scotia Health Research Foundation

    collaborator OTHER_GOV

  • IWK Health Centre

    lead OTHER

Principal Investigators

  • Marsha L Campbell-Yeo, PhD NNP · School of Nursing, Faculty of Health, Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
32 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-12-31
Completion
2021-03-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745963 on ClinicalTrials.gov