Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
1 other identifier
interventional
96
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedAugust 20, 2019
August 1, 2019
1.3 years
August 12, 2019
August 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Immediately post-procedure
Study Arms (3)
Olfactive stimulation intervention with familiarization
EXPERIMENTALParticipants 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.
Olfactive stimulation intervention
EXPERIMENTALParticipants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick.
Standard care
OTHERIn the control arm, participants will receive the standard care for pain which is sucrose administration.
Interventions
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.
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
Eligibility Criteria
You may qualify if:
- years or older,
- speak, understand and write French or English
- express their milk
You may not qualify if:
- \- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
- to 36 weeks of gestation
- APGAR \> 6 at 5 minutes
- less than 21 days
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 29041964BACKGROUNDDe 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
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marilyn Aita, PhD
Université de Montréal
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 20, 2019
Study Start
September 1, 2019
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
August 20, 2019
Record last verified: 2019-08