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Trial of Repeated Analgesia With Kangaroo Care

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01561547
Acronym
TRAKC
Enrollment
242
Registered
2012-03-23
Start date
2012-06-30
Completion date
2016-07-31
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development, Pain

Keywords

pain, preterm neonate, sucrose, kangaroo mother care

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.

Interventions

BEHAVIORALKangaroo Mother Care

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

DIETARY_SUPPLEMENTSucrose

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.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
Nova Scotia Health Research Foundation
CollaboratorOTHER_GOV
Mayday Fund
CollaboratorOTHER
IWK Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Premature Infant Pain Profile (PIPP)At the moment of painful procedureThe 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

MeasureTime frameDescription
Neurobehavioral Assessment of Preterm Infants (NAPI)32, 36 and 40 weeks gestational ageTwo 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026