Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonates Analgesy
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- clinical score assessment PIPP (Premature Infant Pain Profile)
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
clinical score assessment PIPP (Premature Infant Pain Profile)
Time Frame: 20 minutes
Secondary Outcomes
- salivary cortisol level(20 minutes)
- DAN score (Acute Pain of Newborn)(20 minutes)