CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 242 enrolled
Drug / intervention
Kangaroo Mother Care +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01561547
NCT01561547Phase 3Completed

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

IWK Health Centre·interventional·Posted Mar 23, 2012·Updated Sep 20, 2016

In Brief

A Phase 3 clinical trial evaluating Kangaroo Mother Care and Sucrose for Pain and Development. Completed, enrolled 242 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Development
CountriesCanada

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2012
Enrollment StartJun 1, 2012
Primary CompletionMar 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 14.3 years ago

Interventions

Kangaroo Mother Carebehavioral

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

Sucrosedietary

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.