Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Study Overview
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Brief Summary
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Repeated and untreated pain can lead to long-term consequences in preterm infants, such as pain hypersensitivity and impaired motor and intellectual development. Studies on the pharmacological and non-pharmacological interventions for pain management in preterm infants are limited. Thus, we investigated an intervention based on olfactive stimulation with mothers' milk. The aims of this study are: a) Evaluate the effectiveness of an olfactive stimulation intervention with mothers' milk odor on preterm procedural pain; b) Evaluate the effectiveness of adding a period of familiarization previous to the olfactive stimulation intervention with mothers' milk odor on preterm procedural pain. Preterm infants will be recruited and randomly assigned to three groups 1) mothers' milk odor during the nine hours before and during heel-prick, 2) mothers' milk odor during heel-prick, 3) standard care. Pain will be measured using a scale of pain adapted for preterm infants. This procedure with mothers'milk odor is inexpensive and easily performed.This study will significantly contribute to the advancement of knowledge on preterm infants pain management.

Official Title
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Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial

Conditions
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Pain, Acute, Preterm Infant, Breast Milk

Intervention / Treatment
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* Other: Olfactive stimulation intervention with familiarization
* Other: Olfactive stimulation intervention
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for mothers 18 years or older, speak, understand and write French or English express their milk Exclusion Criteria for mothers - pathology or condition that contraindicates the use of their breast milk (HIV, drugs...) Inclusion Criteria for preterm 29 to 36 weeks of gestation APGAR > 6 at 5 minutes less than 21 days Exclusion Criteria for preterm intubated, under Continuous Positive Airway Pressure or nasal oxygen, surgery in the first day of life congenital disease intraventricular hemorrhage > grade II leukomalacia sedation within 48 hours prior to heel prick pharmacologic treatment for pain within 12 hours prior to heel prick being under phototherapy treatment during the familiarization stage

Ages Eligible for Study
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Minimum Age: 29 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Olfactive stimulation intervention with familiarization<br>Participants will receive the olfactive stimulation intervention with mothers' milk odor during a previous period of nine hours and during heel prick. Sucrose will be also administered during heel prick. | Other: Olfactive stimulation intervention with familiarization<br>* The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.<br>|
| Experimental: Olfactive stimulation intervention<br>Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick. | Other: Olfactive stimulation intervention<br>* The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.<br>|
| Other: Standard care<br>In the control arm, participants will receive the standard care for pain which is sucrose administration. | Other: Standard care<br>* Preterm infants will receive sucrose during heel prick.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain : Premature Infant Pain Profile-Revised | Scores range from 0 to 21 where a higher score means more pain, a score less than 6 signifies an absence of pain, and a score greater than 12 indicates moderate to severe pain. The PIPP-R contains four parts: gestational age, state of sleep-awake, physiological parameters, and behavioural parameters. | Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery |  | The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes) | 
| Maternal acceptability of the olfactive stimulation intervention : questionnaire | After the intervention, mothers will be asked to complete a questionnaire focusing on maternal acceptability of the olfactive stimulation intervention with mothers' milk to manage procedural pain (demographic questions and Likert scale). | Immediately post-procedure |