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Prevention of the Procedural Pain in the Newborn (ACTISUCROSE)

Primary Purpose

Prevention of the Procedural Pain in the Newborn

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
saccharose versus breast-feeding
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of the Procedural Pain in the Newborn focused on measuring Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance

Eligibility Criteria

37 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre hospitalier universitaire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

saccharose

breast-feeding

Arm Description

20% saccharose

breast-feeding

Outcomes

Primary Outcome Measures

Increase of the total concentration of haemoglobin
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.

Secondary Outcome Measures

Dosage of rate salivary cortisol
Salivary cortisol sampling

Full Information

First Posted
July 10, 2013
Last Updated
April 21, 2015
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02109263
Brief Title
Prevention of the Procedural Pain in the Newborn
Acronym
ACTISUCROSE
Official Title
Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of the Procedural Pain in the Newborn
Keywords
Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
saccharose
Arm Type
Experimental
Arm Description
20% saccharose
Arm Title
breast-feeding
Arm Type
Placebo Comparator
Arm Description
breast-feeding
Intervention Type
Procedure
Intervention Name(s)
saccharose versus breast-feeding
Intervention Description
saccharose versus breast-feeding
Primary Outcome Measure Information:
Title
Increase of the total concentration of haemoglobin
Description
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.
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
Secondary Outcome Measure Information:
Title
Dosage of rate salivary cortisol
Description
Salivary cortisol sampling
Time Frame
before and after painful gesture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
37 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Michel ROUE
Organizational Affiliation
Pole de la femme, de la Mère et de l'Enfant, CHRU de Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre hospitalier universitaire
City
Brest
ZIP/Postal Code
29200
Country
France

12. IPD Sharing Statement

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Prevention of the Procedural Pain in the Newborn

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