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

September 29, 2015 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Assistance Publique Des Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical score assessment PIPP (Premature Infant Pain Profile)
Time Frame: 20 minutes
20 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
DAN score (Acute Pain of Newborn)
Time Frame: 20 minutes
20 minutes
salivary cortisol level
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Desalbres Urielle, APHM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

January 1, 2016

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

February 4, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 29, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 2012-11
  • RC12_3630 (Registry Identifier: APHM)
  • 2012-A00360-43 (Other Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neonates Analgesy

Clinical Trials on maternal breast milk odor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe