Breast Milk, Pain, Acute, Preterm Infant
Conditions
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.
Interventions
OTHEROlfactive 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.
OTHEROlfactive stimulation intervention
The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
OTHERStandard care
Preterm infants will receive sucrose during heel prick.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
29 Weeks to 36 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain : Premature Infant Pain Profile-Revised | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Contacts
Primary ContactGwenaelle De Clifford-Faugère, PhD student
Backup ContactMarilyn Aita, PhD
Outcome results
None listed