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Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

Primary Purpose

Pain, Acute, Preterm Infant, Breast Milk

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Olfactive stimulation intervention with familiarization
Olfactive stimulation intervention
Standard care
Sponsored by
St. Justine's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

29 Weeks - 36 Weeks (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Other

    Arm Label

    Olfactive stimulation intervention with familiarization

    Olfactive stimulation intervention

    Standard care

    Arm Description

    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.

    Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick.

    In the control arm, participants will receive the standard care for pain which is sucrose administration.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Recovery
    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).

    Full Information

    First Posted
    August 12, 2019
    Last Updated
    August 16, 2019
    Sponsor
    St. Justine's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04062513
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2019 (Anticipated)
    Primary Completion Date
    December 2020 (Anticipated)
    Study Completion Date
    December 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St. Justine's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Acute, Preterm Infant, Breast Milk

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    96 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Olfactive stimulation intervention with familiarization
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Olfactive stimulation intervention
    Arm Type
    Experimental
    Arm Description
    Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick.
    Arm Title
    Standard care
    Arm Type
    Other
    Arm Description
    In the control arm, participants will receive the standard care for pain which is sucrose administration.
    Intervention Type
    Other
    Intervention Name(s)
    Olfactive stimulation intervention with familiarization
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Olfactive stimulation intervention
    Intervention Description
    The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
    Intervention Type
    Other
    Intervention Name(s)
    Standard care
    Intervention Description
    Preterm infants will receive sucrose during heel prick.
    Primary Outcome Measure Information:
    Title
    Pain : Premature Infant Pain Profile-Revised
    Description
    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.
    Time Frame
    Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
    Secondary Outcome Measure Information:
    Title
    Recovery
    Time Frame
    The time required for the preterm infant to return to baseline heart rate levels (should not exceed 5 minutes)
    Title
    Maternal acceptability of the olfactive stimulation intervention : questionnaire
    Description
    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).
    Time Frame
    Immediately post-procedure

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    29 Weeks
    Maximum Age & Unit of Time
    36 Weeks
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gwenaelle De Clifford-Faugère, PhD student
    Phone
    514 343-6111
    Ext
    51473
    Email
    gwenaelle.de.clifford@umontreal.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Marilyn Aita, PhD
    Phone
    514 343-6111
    Ext
    51473
    Email
    marilyn.aita@umontreal.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marilyn Aita, PhD
    Organizational Affiliation
    Université de Montréal
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29041964
    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.
    Results Reference
    background
    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
    Results Reference
    background

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    Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

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