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Clinical Trials/NCT02381691
NCT02381691
Unknown
Not Applicable

Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Assistance Publique Hopitaux De Marseille1 site in 1 country60 target enrollmentJanuary 2013

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
January 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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)

Study Sites (1)

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