Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

NCT ID: NCT04062513

Last Updated: 2019-08-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Pain, Acute; Preterm Infant; Breast Milk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Olfactive stimulation intervention with familiarization

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.

Group Type: EXPERIMENTAL

Olfactive stimulation intervention with familiarization

Intervention Type: OTHER

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 intervention

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

Group Type: EXPERIMENTAL

Olfactive stimulation intervention

Intervention Type: OTHER

The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.

Standard care

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

Group Type: OTHER

Standard care

Intervention Type: OTHER

Preterm infants will receive sucrose during heel prick.

Interventions

Olfactive stimulation intervention with familiarization

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

Olfactive stimulation intervention

The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.

Intervention Type: OTHER

Standard care

Preterm infants will receive sucrose during heel prick.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 29 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Justine's Hospital

OTHER

Sponsor Role: lead

Responsible Party

De Clifford-Faugère Gwenaelle

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marilyn Aita, PhD

Role: STUDY_DIRECTOR

Université de Montréal

Central Contacts

Gwenaelle De Clifford-Faugère, PhD student

Role: CONTACT

gwenaelle.de.clifford@umontreal.ca

514 343-6111 ext. 51473

Marilyn Aita, PhD

Role: CONTACT

marilyn.aita@umontreal.ca

514 343-6111 ext. 51473

References

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.

Reference Type: BACKGROUND

PMID: 29041964 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

MP-21-2020-2309

Identifier Type: -

Identifier Source: org_study_id