NewbornPhase 3BBSUCROSENCT02374281
Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking
A Phase 3 study testing Glucose sucking, Water sucking and No sucking in people with Newborn and Neonatal Screening, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Newborn, Neonatal Screening
- What is being tested?
- Glucose sucking, Water sucking and No sucking
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Apr 2015
- Phase
- Phase 3
- 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 Up to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test
- Establishing consent form signed by the holder of parental authority
Who cannot join
- Children suffering from a disease affecting the central nervous system.
- Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration.
- Newborns impregnated with a prepartum maternal analgesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.
The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions.
Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).
Read the detailed description
The investigators want to show that the short term autonomic nervous system (ANS) response, after a nociceptive action in the new-born in maternity depends on whether it is preceded by non-nutritive sucking and / or sucrose administration.
- Conditions
- Newborn, Neonatal Screening
- Being tested
- Glucose sucking, Water sucking, No sucking
- Keywords
- Newborn, Neonatal Screening, Autonomic Nervous System, Pain, non-nutritive sucking, sucrose administration, nociceptive action, Electro acoustical characteristics of crying
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose suckingDrug
Also called Glucose PROAMP 30%, Laboratoires AGUETTANT
Water suckingDrug
Also called Eau ppi, BRAUN
No suckingOther
| Study group | Role | What they receive |
|---|---|---|
| Glucose sucking | Experimental | The newborn will receive one minute before the painful care either a compress with sucrose.
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
Glucose 30% by oral route (1 ml). Receives: Drug: Glucose sucking |
| Water sucking | Active comparator | The newborn will receive one minute before the painful care either a compress with water.
The puncture made in the veins of the back of the hand, will be performed only once per patient per test.
Sterile water by oral route (1 ml). Receives: Drug: Water sucking |
| No sucking | Placebo comparator | The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Receives: Other: No sucking |
What is being measured
The primary outcome is the main question the study is designed to answer.
High frequency normalized index (HFnu)
It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor.
Measured: From 15 min before the painful care to 15 min after.
Secondary outcomes (8)
Low frequency (LF and LFnu),
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Measured: From 15 min before the painful care to 15 min after.
Scale of hetero-assessment of pain (DAN)
The DAN scale is specific to acute pain of the newborn
Measured: 15 minutes after the painful care
Electro acoustical characteristic of crying newborn : Duration
An acoustic recording of children's tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress
Measured: From 15 min before the painful care to 15 min after.
Frequency domain
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Measured: From 15 min before the painful care to 15 min after.
The time domain (SDNN, SDANN, pNN50).
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Measured: From 15 min before the painful care to 15 min after.
LF / HF ratio
It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor.
Measured: From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency
An acoustic recording of children's tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress
Measured: From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency variations
An acoustic recording of children's tears will be conducted in parallel with a microphone and dedicated software to study the properties of crying caused by the puncture. Continuous recording begins at least fifteen minutes before the procedure and is kept up to fifteen minutes after the invasive procedure. The child must be quiet. It will be placed in its cocoon to limit environmental stress
Measured: From 15 min before the painful care to 15 min after.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NewbornStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374281
- Sponsor's protocol ID
- 1308143
- Other IDs
- 2013-005043-86
- Acronym
- BBSUCROSE
- Status last verified
- Mar 2016
- First submitted
- 10 Feb 2015
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Nervous System Reactivity of the Newborn After a Nociceptive Stress: Interest of Sucrose and Non-nutritive Sucking : A Controlled Randomized Single-center Study.
- ClinicalTrials.gov ID
- NCT02374281
- Acronym / sponsor ID
- BBSUCROSE / 1308143
- Conditions
- Newborn, Neonatal Screening
- Keywords
- Newborn, Neonatal Screening, Autonomic Nervous System, Pain, non-nutritive sucking, sucrose administration, nociceptive action, Electro acoustical characteristics of crying
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 27 Feb 2015 (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 management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions.
Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).
Detailed description
The investigators want to show that the short term autonomic nervous system (ANS) response, after a nociceptive action in the new-born in maternity depends on whether it is preceded by non-nutritive sucking and / or sucrose administration.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose sucking | Experimental | Drug: Glucose suckingThe newborn will receive one minute before the painful care either a compress with sucrose. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Glucose 30% by oral route (1 ml). |
| Water sucking | Active comparator | Drug: Water suckingThe newborn will receive one minute before the painful care either a compress with water. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Sterile water by oral route (1 ml). |
| No sucking | Placebo comparator | Other: No suckingThe puncture made in the veins of the back of the hand, will be performed only once per patient per test. |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test
- Establishing consent form signed by the holder of parental authority
Key exclusion criteria (3 listed)
- Children suffering from a disease affecting the central nervous system.
- Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration.
- Newborns impregnated with a prepartum maternal analgesia.
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 |
|---|---|---|
| Glucose suckingAlso: Glucose PROAMP 30%, Laboratoires AGUETTANT | Drug | Glucose sucking |
| Water suckingAlso: Eau ppi, BRAUN | Drug | Water sucking |
| No sucking | Other | No sucking |
Primary outcome
High frequency normalized index (HFnu)
Time frame: From 15 min before the painful care to 15 min after.
It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor.
8 secondary outcomes
Low frequency (LF and LFnu),
Time frame: From 15 min before the painful care to 15 min after.
Scale of hetero-assessment of pain (DAN)
Time frame: 15 minutes after the painful care
Electro acoustical characteristic of crying newborn : Duration
Time frame: From 15 min before the painful care to 15 min after.
Frequency domain
Time frame: From 15 min before the painful care to 15 min after.
The time domain (SDNN, SDANN, pNN50).
Time frame: From 15 min before the painful care to 15 min after.
LF / HF ratio
Time frame: From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency
Time frame: From 15 min before the painful care to 15 min after.
Electro acoustical characteristic of crying newborn : Frequency variations
Time frame: From 15 min before the painful care to 15 min after.
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 30 Mar 2016.
- Individual participant dataSharing planned: No
Related trials for Newborn
Recruiting
Fecal Microbiota Transplantation (FMT) as a Prophylaxis of Necrotizing Enterocolitis (NEC) - Clinical Study
Necrotizing Enterocolitis (NEC), Necrotizing Enterocolitis of Newborn
RecruitingPhase 3
A Study of Nipocalimab in Pregnancies at Risk for Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Hemolytic Disease of the Fetus and Newborn
RecruitingObservational study
A Study on Hemolytic Disease of the Fetus and Newborn (HDFN) Through Global Registry
Hemolytic Disease of the Fetus and Newborn
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
Pulmonary Hypertension of Newborn, Diaphragm Defect
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.
Hugues PATURAL, MD PhD principal investigator
CHU de Saint-Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Glucose sucking, Water sucking and No sucking in people with Newborn and Neonatal Screening, run by Centre Hospitalier Universitaire de Saint Etienne 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 2 inclusion and 3 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 30 Mar 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
High frequency normalized index (HFnu) (time frame: From 15 min before the painful care to 15 min after.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2016; AzTrials last refreshed its copy on 8 Nov 2026.