Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response

St. Justine's Hospital

Status: Unknown

Conditions: Breast Milk; Preterm Infant; Pain, Acute

Treatments: Other: Olfactive stimulation intervention with familiarization; Other: Olfactive stimulation intervention; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT04062513

MP-21-2020-2309

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 29 to 36 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 3 patient groups

Olfactive stimulation intervention with familiarization

Experimental group

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.

Treatment:

Other: Olfactive stimulation intervention with familiarization

Olfactive stimulation intervention

Experimental group

Description:

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

Treatment:

Other: Olfactive stimulation intervention

Standard care

Other group

Description:

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

Treatment:

Other: Standard care