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Completed

NCT Number: NCT01561547

Trial of Repeated Analgesia With Kangaroo Care

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

IWKHealthC

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kangaroo Mother Care

Behavioral

Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.

Sucrose

Dietary Supplement

24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.

Primary outcomes

  1. 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

  1. Neurobehavioral Assessment of Preterm Infants (NAPI)

    Time frame: 32, 36 and 40 weeks gestational age

    Two scales of the NAPI will be scored by person blinded to the intervention. These are 1) Motor Development and Vigour and 2) Alertness and Orientation

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Mayday Fund
  • Nova Scotia Health Research Foundation

Registry information

Official study title

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

Acronym: TRAKC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Mar 23, 2012
Registry last updated
Sep 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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