Prevention of the Procedural Pain in the Newborn (ACTISUCROSE)

April 21, 2015 updated by: University Hospital, Brest

Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn

The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Study Type

Interventional

Enrollment (Actual)

114

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
      • Brest, France, 29200
        • Centre Hospitalier Universitaire

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

8 months to 9 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestationnel age included between 37 and 42 weeks
  • Born in the CHRU of Brest
  • Breast-Fed
  • Score of Apgar upper to 7
  • No pathology malformative
  • Absence of known chromosomal abnormality
  • Consent of parents

Exclusion Criteria:

  • Maternal drug use
  • Morphinic treatment
  • Barbiturate treatment
  • Benzodiazépine treatment

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: saccharose
20% saccharose
Procedure: saccharose versus breast-feeding
saccharose versus breast-feeding
Placebo Comparator: breast-feeding
Procedure: saccharose versus breast-feeding
saccharose versus breast-feeding

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase of the total concentration of haemoglobin
Time Frame: Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.
Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dosage of rate salivary cortisol
Time Frame: before and after painful gesture
Salivary cortisol sampling
before and after painful gesture

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Jean-Michel ROUE, Pole de la femme, de la Mère et de l'Enfant, CHRU de Brest

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

June 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

July 10, 2013

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RB 12.143

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.

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