Clinical trial NCT04062513: Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
Official title: Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Acute
Preterm Infant
Breast Milk
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2019-08-20
Enrollment: 96
Sex: ALL
Minimum age (years): 29
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain : Premature Infant Pain Profile-Revised
timeFrame: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
Secondary outcomes:
measure: Recovery
timeFrame: The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
measure: Maternal acceptability of the olfactive stimulation intervention : questionnaire
timeFrame: Immediately post-procedure
Other outcomes:
Locations:
Study officials:
affiliation: Université de Montréal
name: Marilyn Aita, PhD
role: STUDY_DIRECTOR
References:
citation: De Clifford-Faugere G, Lavallee A, Aita M. Olfactive stimulation interventions for managing procedural pain in preterm and full-term neonates: a systematic review protocol. Syst Rev. 2017 Oct 17;6(1):203. doi: 10.1186/s13643-017-0589-1.
citation: De Clifford-Faugère G, Aita M, Héon M, Le May S. Management of procedural pain in preterm infants through olfactive stimulation with mothers' milk: A pilot study. Science of Nursing and Health Practices - Science infirmière et pratiques en santé. 2(1), Article 3, 2019. Available at: https://doi.org/10.31770/2561-7516.1042