Pain, AcuteNCT04062513
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
A study testing Olfactive stimulation intervention with familiarization and Olfactive stimulation intervention in people with Pain, Acute and Preterm Infant, run by St. Justine's Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 29 to 36 weeksHealthy volunteers can take part
- Conditions the study is for
- Pain, Acute, Preterm Infant, Breast Milk
- What is being tested?
- Olfactive stimulation intervention with familiarization and Olfactive stimulation intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 29 to 36 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 18 years or older,
- speak, understand and write French or English
- express their milk
- 29 to 36 weeks of gestation
- APGAR > 6 at 5 minutes
- less than 21 days
Who cannot join
- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
- intubated, under Continuous Positive Airway Pressure or nasal oxygen,
- surgery in the first day of life
- congenital disease
- intraventricular hemorrhage > grade II
- leukomalacia
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- 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
Trial locations and contacts
No sites are listed yet.
Gwenaelle De Clifford-Faugère, PhD student contact
About this study
Official title: Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
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.
- Conditions
- Pain, Acute, Preterm Infant, Breast Milk
- Being tested
- Olfactive stimulation intervention with familiarization, Olfactive stimulation intervention, Standard care
- Medical subject headings
- Acute Pain, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactive stimulation intervention with familiarizationOther
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.
Olfactive stimulation interventionOther
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
Standard careOther
Preterm infants will receive sucrose during heel prick.
| Study group | Role | What they receive |
|---|---|---|
| Olfactive stimulation intervention with familiarization | Experimental | 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. Receives: Other: Olfactive stimulation intervention with familiarization |
| Olfactive stimulation intervention | Experimental | Participants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick. Receives: Other: Olfactive stimulation intervention |
| Standard care | Other | In the control arm, participants will receive the standard care for pain which is sucrose administration. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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).
Measured: Immediately post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Clifford-Faugère Gwenaelle, St. Justine's Hospital
- Investigators
- Marilyn Aita, PhD, Study director, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062513
- Sponsor's protocol ID
- MP-21-2020-2309
- Status last verified
- Aug 2019
- First submitted
- 12 Aug 2019
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 29041964De 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04062513
- Acronym / sponsor ID
- MP-21-2020-2309
- Conditions
- Pain, Acute, Preterm Infant, Breast Milk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olfactive stimulation intervention with familiarization | Experimental | Other: Olfactive stimulation intervention with familiarizationParticipants 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 | Experimental | Other: Olfactive stimulation interventionParticipants will receive the olfactive stimulation intervention with mothers' milk odor during heel prick only. Sucrose will be also administered during heel prick. |
| Standard care | Other | Other: Standard careIn the control arm, participants will receive the standard care for pain which is sucrose administration. |
Who may qualify
- Ages
- 29 to 36 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 18 years or older,
- speak, understand and write French or English
- express their milk
- 29 to 36 weeks of gestation
- APGAR > 6 at 5 minutes
Key exclusion criteria (9 listed)
- pathology or condition that contraindicates the use of their breast milk (HIV, drugs...)
- intubated, under Continuous Positive Airway Pressure or nasal oxygen,
- surgery in the first day of life
- congenital disease
- intraventricular hemorrhage > grade II
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Olfactive stimulation intervention with familiarizationThe 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. | Other | Olfactive stimulation intervention with familiarization |
| Olfactive stimulation interventionThe intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. | Other | Olfactive stimulation intervention |
| Standard carePreterm infants will receive sucrose during heel prick. | Other | Standard care |
Primary outcome
Pain : Premature Infant Pain Profile-Revised
Time frame: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection
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.
2 secondary outcomes
Recovery
Time frame: 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
Time frame: Immediately post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2019.
- Background: PubMed 29041964De 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.
- BackgroundDe 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gwenaelle De Clifford-Faugère, PhD student contact
Marilyn Aita, PhD study director
Université de Montréal
Questions about this trial
What is this clinical trial studying?
A study testing Olfactive stimulation intervention with familiarization and Olfactive stimulation intervention in people with Pain, Acute and Preterm Infant, run by St. Justine's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gwenaelle De Clifford-Faugère, PhD student (514 343-6111 ext. 51473, gwenaelle.de.clifford@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain : Premature Infant Pain Profile-Revised (time frame: Change from baseline every 30 seconds until 120 seconds post heel lance and 30 seconds after the end of blood collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062513, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2019.