Trial of Repeated Analgesia With Kangaroo Care

Phase 3

Completed

• Conditions: Development; Pain
• Interventions: Behavioral: Kangaroo Mother Care; Dietary Supplement: Sucrose

• Registration Number: NCT01561547
• Lead Sponsor: IWK Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-08
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Study Start: 2012-06
• Primary Completion: 2016-03
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-17
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination Kangaroo Mother Care and Sucrose	Kangaroo Mother Care	Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.
Combination Kangaroo Mother Care and Sucrose	Sucrose	Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.
Kangaroo Mother Care	Kangaroo Mother Care	Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.
Sucrose	Sucrose	Two minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important.

Primary Outcome Measures

Name	Time	Method
Premature Infant Pain Profile (PIPP)	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 Outcome Measures

Name	Time	Method
Neurobehavioral Assessment of Preterm Infants (NAPI)	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

Trial Locations

Locations (1)

IWKHealthC; 🇨🇦 Halifax, Nova Scotia, Canada