Prevention of the Procedural Pain in the NewbornACTISUCROSENCT02109263
Prevention of the Procedural Pain in the Newborn
A study testing saccharose versus breast-feeding in people with Prevention of the Procedural Pain in the Newborn, run by University Hospital, Brest at 1 site in France.
Trial 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) Read more about this study
- Who is it for?
- Ages 37 to 42 weeks
- Conditions the study is for
- Prevention of the Procedural Pain in the Newborn
- What is being tested?
- saccharose versus breast-feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 37 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Maternal drug use
- Morphinic treatment
- Barbiturate treatment
- Benzodiazépine treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Being tested
- saccharose versus breast-feeding
- Keywords
- Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saccharose versus breast-feedingProcedure or surgery
saccharose versus breast-feeding
| Study group | Role | What they receive |
|---|---|---|
| saccharose | Experimental | 20% saccharose Receives: Procedure: saccharose versus breast-feeding |
| breast-feeding | Placebo comparator | breast-feeding Receives: Procedure: saccharose versus breast-feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of the total concentration of haemoglobin
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.
Measured: 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 outcomes (1)
Dosage of rate salivary cortisol
Salivary cortisol sampling
Measured: before and after painful gesture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startJun 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prevention of the Procedural Pain in the NewbornStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Michel ROUE, Principal investigator, Pole de la femme, de la Mère et de l'Enfant, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109263
- Sponsor's protocol ID
- RB 12.143
- Acronym
- ACTISUCROSE
- Status last verified
- Apr 2015
- First submitted
- 10 Jul 2013
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rioualen S, Durier V, Herve D, Misery L, Sizun J, Roue JM. Cortical Pain Response of Newborn Infants to Venepuncture: A Randomized Controlled Trial Comparing Analgesic Effects of Sucrose Versus Breastfeeding. Clin J Pain. 2018 Jul;34(7):650-656. doi: 10.1097/AJP.0000000000000581.
PubMed 29298184
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn
- ClinicalTrials.gov ID
- NCT02109263
- Acronym / sponsor ID
- ACTISUCROSE / RB 12.143
- Keywords
- Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| saccharose | Experimental | Procedure: saccharose versus breast-feeding20% saccharose |
| breast-feeding | Placebo comparator | Procedure: saccharose versus breast-feedingbreast-feeding |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- Maternal drug use
- Morphinic treatment
- Barbiturate treatment
- Benzodiazépine treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saccharose versus breast-feedingsaccharose versus breast-feeding | Procedure or surgery | breast-feeding, saccharose |
Primary outcome
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.
1 secondary outcome
Dosage of rate salivary cortisol
Time frame: before and after painful gesture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 29298184Rioualen S, Durier V, Herve D, Misery L, Sizun J, Roue JM. Cortical Pain Response of Newborn Infants to Venepuncture: A Randomized Controlled Trial Comparing Analgesic Effects of Sucrose Versus Breastfeeding. Clin J Pain. 2018 Jul;34(7):650-656. doi: 10.1097/AJP.0000000000000581.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel ROUE principal investigator
Pole de la femme, de la Mère et de l'Enfant, CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing saccharose versus breast-feeding in people with Prevention of the Procedural Pain in the Newborn, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02109263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.