Trial of Repeated Analgesia With Kangaroo Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Development

Intervention / Treatment
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* Behavioral: Kangaroo Mother Care
* Dietary Supplement: Sucrose


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kangaroo Mother Care<br>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. | Behavioral: Kangaroo Mother Care<br>* Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.<br>|
| Active Comparator: Sucrose<br>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. | Dietary Supplement: Sucrose<br>* 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.<br>|
| Experimental: Combination Kangaroo Mother Care and Sucrose<br>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. | Behavioral: Kangaroo Mother Care<br>* Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.<br>Dietary Supplement: Sucrose<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Premature Infant Pain Profile (PIPP) | 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. | At the moment of painful procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurobehavioral Assessment of Preterm Infants (NAPI) | 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 | 32, 36 and 40 weeks gestational age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, preterm neonate, sucrose, kangaroo mother care