Overview

This trial is active, not recruiting.

Condition neonates analgesy
Treatments maternal breast milk odor, no odor
Sponsor Assistance Publique Hopitaux De Marseille
Start date January 2013
End date January 2016
Trial size 60 participants
Trial identifier NCT02381691, 2012-11, 2012-A00360-43, RC12_3630

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused.
maternal breast milk odor
(Placebo Comparator)
In a second control group, venipuncture was performed to the neonate with an odorless diffusor.
no odor

Primary Outcomes

Measure
clinical score assessment PIPP (Premature Infant Pain Profile)
time frame: 20 minutes

Secondary Outcomes

Measure
DAN score (Acute Pain of Newborn)
time frame: 20 minutes
salivary cortisol level
time frame: 20 minutes

Eligibility Criteria

Male or female participants up to 10 days old.

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

Additional Information

Official title Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.