Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Study Overview
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Brief Summary
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Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial. Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture. In the first group breast milk, venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.

Official Title
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Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Conditions
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Neonates Analgesy

Intervention / Treatment
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* Other: maternal breast milk odor
* Other: no odor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, postnatal age ≤ 10 days birth weight greater than the 5th percentile according to Olsen curves et al. clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease the two legal representatives must have signed an informed consent. Exclusion Criteria: neonates for whom no video was recorded during the venipuncture

Ages Eligible for Study
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Maximum Age: 10 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: maternal breast milk odor<br>In the first group breast milk, venipuncture was performed to the neonate while his mother's milk odor was being diffused. | Other: maternal breast milk odor<br> <br> |
| Placebo Comparator: no odor<br>In a second control group, venipuncture was performed to the neonate with an odorless diffusor. | Other: no odor<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical score assessment PIPP (Premature Infant Pain Profile) |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAN score (Acute Pain of Newborn) |  | 20 minutes | 
| salivary cortisol level |  | 20 minutes |