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Clinical Trials/NCT01561547
NCT01561547
Completed
Phase 3

Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?

IWK Health Centre1 site in 1 country242 target enrollmentJune 2012
ConditionsPainDevelopment

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Pain
Sponsor
IWK Health Centre
Enrollment
242
Locations
1
Primary Endpoint
Premature Infant Pain Profile (PIPP)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.

AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
July 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Celeste Johnston

Principal Investigator

IWK Health Centre

Eligibility Criteria

Inclusion Criteria

  • less than 36.0 weeks gestational age
  • mother is generally available to provide kangaroo mother care

Exclusion Criteria

  • narcotic analgesics
  • surgery in past 48 hrs
  • major congenital anomalies

Outcomes

Primary Outcomes

Premature Infant Pain Profile (PIPP)

Time Frame: At the moment of painful procedure

The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.

Secondary Outcomes

  • Neurobehavioral Assessment of Preterm Infants (NAPI)(32, 36 and 40 weeks gestational age)

Study Sites (1)

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