Neonates Analgesy Clinical Trial
Official title:
Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care