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

Not Applicable

• Conditions: Neonates Analgesy
• Interventions: Other: maternal breast milk odor; Other: no odor

• Registration Number: NCT02381691
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-02-04
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-29
• Last Update Posted: 2015-10-01
• Primary Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
maternal breast milk odor	maternal breast milk odor	In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused.
no odor	no odor	In a second control group, venipuncture was performed to the neonate with an odorless diffusor.

Primary Outcome Measures

Name	Time	Method
clinical score assessment PIPP (Premature Infant Pain Profile)	20 minutes

Secondary Outcome Measures

Name	Time	Method
salivary cortisol level	20 minutes
DAN score (Acute Pain of Newborn)	20 minutes

Trial Locations

Locations (1)

Assistance Publique des Hopitaux de Marseille; 🇫🇷 Marseille, France