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
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
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
NCT ID
NCT02109263
First Posted
July 10, 2013
Last Updated
April 21, 2015
Sponsor
University Hospital, Brest
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
Learn more about this trial
Prevention of the Procedural Pain in the Newborn
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