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.
| Status | Active, not recruiting |
| Enrollment | 60 |
| Est. completion date | |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 10 Days |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique des Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical score assessment PIPP (Premature Infant Pain Profile) | 20 minutes | No | |
| Secondary | DAN score (Acute Pain of Newborn) | 20 minutes | No | |
| Secondary | salivary cortisol level | 20 minutes | No |