Premature BirthNIPE-DOLNCT02764424
Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance
An observational study of Premature Birth and Newborn, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Read more about this study
- Who is it for?
- Ages Up to 3 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth, Newborn
- What is being tested?
- NIPE (MDoloris®)
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2016to 1 Nov 2016
- Phase
- Observational
- 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 3 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Neonates over 26 weeks of Gestational Age and under 3 months hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France) will be eligible. They will have to perform a potentially painful care (for example an administration of substances by intramuscular way) in the usual care context.
Who may be able to join
- Neonates over 26 weeks of Gestational Age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France);
- Neonates with a potentially painful move programmed (dextro, administration of substances by intramuscular, arterial/ venipuncture, change nasogastric tube, tracheal aspirates).
Who cannot join
- Newborns sedated;
- Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance : Interest of the Co-evaluation of NIPE and Hetero-assessment Scale : the NIPE-DOL Study
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.
Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.
Read more
The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).
The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.
Read the detailed description
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.
Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. Clinical correlations have been completed for adult patients during or after general anesthesia. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.
The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).
The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.
Concurrent analysis of autonomic markers (orthosympathetic and parasympathetic indices from time or frequency domain analysis of heart rate variability) will be correlated with the NIPE index in order to study confounding factors that can induce a sympathetic stress without pain sensation and can thus change the indices of nociception.
This study based on a real-time analysis of the perception of pain for newborns is a step for the validation of this new tool that could facilitate the real-time newborn pain management. Furthermore, it will allow caregivers the opportunity to adjust therapeutics in non-communicative patients.
- Conditions
- Premature Birth, Newborn
- Being tested
- NIPE (MDoloris®)
- Keywords
- Newborn, Heart Rate Variability (HRV), Analgesic Nociception Index (ANI), Autonomous Nervous System (ANS)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIPE (MDoloris®)Device
Also called Newborn Infant Parasympathetic Evaluation index
Each file consists of a simultaneous recording of an electrocardiogram signal according to usual practice (cardiac monitor PHILIPS), coupled with a concomitant registration of NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). The electrocardiogram signal, respiration rate, oxygen saturation (SpO2) and NIPE are recorded simultaneously on a computer with a capture card. The other indices of Heart Rate Variability will be analyzed offline.
| Study group | Role | What they receive |
|---|---|---|
| Preterm or term newborns | Preterm or term newborns, hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care will be included in the study. This painful stress is made in the patient's usual care and is not modified by the protocol. Their stress due to the painful stimuli will be measured with different scales (2 PIPP (Premature Infant Pain Profile) and DAN (Newborn Acute Pain)) and compared with the index obtained with the NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). Receives: Device: NIPE (MDoloris®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIPE index
Newborn Infant Parasympathetic Evaluation (NIPE) index obtained will be compared to the Premature Infant Pain Profile (PIPP) and ("Douleur Aiguë du Nouveau Né" - Newborn Acute Pain (DAN) scores.
Measured: Day 1
Secondary outcomes (2)
Orthosympathetic and parasympathetic indices
Compare the changes of orthosympathetic and parasympathetic indices in the time and frequency domains of heart rate variability, with respect to changes of NIPE (Newborn Infant Parasympathetic Evaluation) and PIPP-R (Premature Infant Pain Profile) / DAN (Newborn Acute Pain) scores.
Measured: Day 1
Changes in the NIPE index
Ensure consistency of changes in levels of pain felt (PIPP score / DAN score) with changes in NIPE index, in the same patient.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start1 Jul 2016
- Primary completion1 Nov 2016
- Study completion1 Nov 2016
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 Premature BirthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugues PATURAL, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764424
- Sponsor's protocol ID
- 1600008
- Other IDs
- 1954454
- Acronym
- NIPE-DOL
- Status last verified
- Oct 2018
- First submitted
- 4 May 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cremillieux C, Makhlouf A, Pichot V, Trombert B, Patural H. Objective assessment of induced acute pain in neonatology with the Newborn Infant Parasympathetic Evaluation index. Eur J Pain. 2018 Jul;22(6):1071-1079. doi: 10.1002/ejp.1191. Epub 2018 Mar 24.
PubMed 29369446
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management in Neonatal Intensive Care Units by Studying the Autonomic Balance : Interest of the Co-evaluation of NIPE and Hetero-assessment Scale : the NIPE-DOL Study
- ClinicalTrials.gov ID
- NCT02764424
- Acronym / sponsor ID
- NIPE-DOL / 1600008
- Conditions
- Premature Birth, Newborn
- Keywords
- Newborn, Heart Rate Variability (HRV), Analgesic Nociception Index (ANI), Autonomous Nervous System (ANS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Nov 2016 (actual)
- First posted
- 6 May 2016 (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.
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.
Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.
The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).
The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.
Detailed description
Fight against the pain caused by the disease or by the diagnostic and therapeutic procedures is a daily and essential concern for the caregiver neonatologist. The quantification of pain is needed to effectively adjust analgesic therapy and by the way, to limit side effects. Several pain scales are now validated for newborns but they are based on one-off measures and hetero assessments often dependent on many factors including the operator.
Recent developments in the real time analysis of the cardiac signal under the influence of autonomic control, have led to the development of a new painful stress index. A monitor has recently been developed by Mdoloris® company and provides an Analgesia and Nociception Index (ANI index in children and adults and NIPE index - for Newborn Infant Parasympathetic Evaluation - in newborns). It is based on the study of the heart rate variability and the variations of the sympathetic and parasympathetic indices to stimuli. Clinical correlations have been completed for adult patients during or after general anesthesia. The validation of this nociception index has not been validated in a neonatal unit where special attention is paid to pain control.
The main purpose of our study is to show the consistency of this NIPE index (adapted to newborns) from 2 validated pain scales routinely used in neonatology in non-sedated children, hospitalized in intensive unit and neonatal intensive care unit from the University Hospital of Saint-Etienne (France).
The study will involve 40 preterm or term newborn (i.e. with a gestational age between 26 and 42 weeks and less than 3 months of life), hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care.
Concurrent analysis of autonomic markers (orthosympathetic and parasympathetic indices from time or frequency domain analysis of heart rate variability) will be correlated with the NIPE index in order to study confounding factors that can induce a sympathetic stress without pain sensation and can thus change the indices of nociception.
This study based on a real-time analysis of the perception of pain for newborns is a step for the validation of this new tool that could facilitate the real-time newborn pain management. Furthermore, it will allow caregivers the opportunity to adjust therapeutics in non-communicative patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preterm or term newborns | – | Device: NIPE (MDoloris®)Preterm or term newborns, hospitalized in neonatal intensive care units of our university hospital (Saint-Etienne - France), who have to acute painful stimuli related to their care will be included in the study. This painful stress is made in the patient's usual care and is not modified by the protocol. Their stress due to the painful stimuli will be measured with different scales (2 PIPP (Premature Infant Pain Profile) and DAN (Newborn Acute Pain)) and compared with the index obtained with the NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Neonates over 26 weeks of Gestational Age and under 3 months hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France) will be eligible. They will have to perform a potentially painful care (for example an administration of substances by intramuscular way) in the usual care context.
Key inclusion criteria (2 listed)
- Neonates over 26 weeks of Gestational Age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France);
- Neonates with a potentially painful move programmed (dextro, administration of substances by intramuscular, arterial/ venipuncture, change nasogastric tube, tracheal aspirates).
Key exclusion criteria (2 listed)
- Newborns sedated;
- Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
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 |
|---|---|---|
| NIPE (MDoloris®)Also: Newborn Infant Parasympathetic Evaluation indexEach file consists of a simultaneous recording of an electrocardiogram signal according to usual practice (cardiac monitor PHILIPS), coupled with a concomitant registration of NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). The electrocardiogram signal, respiration rate, oxygen saturation (SpO2) and NIPE are recorded simultaneously on a computer with a capture card. The other indices of Heart Rate Variability will be analyzed offline. | Device | Preterm or term newborns |
Primary outcome
NIPE index
Time frame: Day 1
Newborn Infant Parasympathetic Evaluation (NIPE) index obtained will be compared to the Premature Infant Pain Profile (PIPP) and ("Douleur Aiguë du Nouveau Né" - Newborn Acute Pain (DAN) scores.
2 secondary outcomes
Orthosympathetic and parasympathetic indices
Time frame: Day 1
Changes in the NIPE index
Time frame: Day 1
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 25 Oct 2018.
- Results publication: PubMed 29369446Cremillieux C, Makhlouf A, Pichot V, Trombert B, Patural H. Objective assessment of induced acute pain in neonatology with the Newborn Infant Parasympathetic Evaluation index. Eur J Pain. 2018 Jul;22(6):1071-1079. doi: 10.1002/ejp.1191. Epub 2018 Mar 24.
- Individual participant dataSharing planned: No
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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 principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Birth and Newborn, 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 2 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 25 Oct 2018. 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. 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?
NIPE index (time frame: Day 1). 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 NCT02764424, 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 25 Oct 2018.