Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT02381691|
Recruitment Status : Unknown
Verified September 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : October 1, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Neonates Analgesy||Other: maternal breast milk odor Other: no odor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||January 2016|
Experimental: 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.
Other: maternal breast milk odor
Placebo Comparator: no odor
In a second control group, venipuncture was performed to the neonate with an odorless diffusor.
Other: no odor
- clinical score assessment PIPP (Premature Infant Pain Profile) [ Time Frame: 20 minutes ]
- DAN score (Acute Pain of Newborn) [ Time Frame: 20 minutes ]
- salivary cortisol level [ Time Frame: 20 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381691
|Assistance Publique des Hopitaux de Marseille|
|Study Director:||Desalbres Urielle||APHM|