NeonatalNIPEprémaNCT05223790
Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
An observational study of Neonatal and Pain Measurement, run by University Hospital, Lille at 1 site in France.
Trial summary
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component). Read more about this study
- Who is it for?
- Ages 0 to 7 days
- Conditions the study is for
- Neonatal, Pain Measurement, Reanimation
- What is being tested?
- Pain measurement during care procedures in neonatal reanimation
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 21 Apr 2022to 13 Jan 2025
- 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 0 to 7 days
- All sexes
- No healthy volunteers
- Child
Study population: Infant born very premature and aged less than 8 days ventilated and sedated in neonatal reanimation
Who may be able to join
- Infant born very premature before 34 weeks of amenorrhoea + 0 day
- Age ≤ 7 days
- Admitted in neonatal reanimation
- Sedated, intubated, ventilated
Who cannot join
- High frequency oscillation ventilation
- Heart rate non sinusal
- Inotropes and atropine
- Opposition from the guardian of parental authority
- Difficulty of comprehension or communication making the parental information impossible
Trial locations and contacts
1 site in 1 country.
About this study
The Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component).
So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.
- Conditions
- Neonatal, Pain Measurement, Reanimation
- Being tested
- Pain measurement during care procedures in neonatal reanimation
- Keywords
- NIPE, Newborn Infant Parasympathetic Evaluation, Pain measurement, Neonatal care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain measurement during care procedures in neonatal reanimationDevice
Pain measurement during care procedures in neonatal reanimation
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of the NIPE measures between before and during care.
Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after.
Measured: From 10 minutes before the care to 10 minutes after the beginning of the care
Secondary outcomes (3)
Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period
The average of NIPE mesures 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures.
Measured: From 10 minutes after the beginning of the care to 10 minutes after the end of the care
Correlation between the NIPEmin and the PIPP-R behavioural scale for each period
The lowest NIPE mesures during the 10 minutes before care, 10 minutes after the begining and 10 minutes after the end of the care were collected. And the same for the PIPP-R behavioral scale mesures.
Measured: From 10 minutes before the care to 10 minutes after the care
The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale
Study the discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale
Measured: From 10 minutes before the care to 10 minutes after the care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start21 Apr 2022
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeonatalStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Riadh Boukris, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223790
- Sponsor's protocol ID
- 2021_0238
- Acronym
- NIPEpréma
- Status last verified
- Apr 2026
- First submitted
- 17 Dec 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the NIPE in Very Premature Infant Ventilated and Sedated in Neonatal Reanimation.
- ClinicalTrials.gov ID
- NCT05223790
- Acronym / sponsor ID
- NIPEpréma / 2021_0238
- Conditions
- Neonatal, Pain Measurement, Reanimation
- Keywords
- NIPE, Newborn Infant Parasympathetic Evaluation, Pain measurement, Neonatal care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 4 Feb 2022 (actual)
- 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 Newborn Infant Parasympathetic Evaluation (NIPE) was developed as a method of analysis of the heart rate variability. The monitor gives a value between 0 (low value of the parasympathetic component) and 100 (high value of the parasympathetic component).
So far, the measure of the heart failure variability by using the NIPE in infant born very premature ventilated and sedated in neonatal reanimation has not been realised and validated as an evaluation method of the pain and discomfort related to neonatal care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infant born very premature and aged less than 8 days ventilated and sedated in neonatal reanimation
Key inclusion criteria (4 listed)
- Infant born very premature before 34 weeks of amenorrhoea + 0 day
- Age ≤ 7 days
- Admitted in neonatal reanimation
- Sedated, intubated, ventilated
Key exclusion criteria (5 listed)
- High frequency oscillation ventilation
- Heart rate non sinusal
- Inotropes and atropine
- Opposition from the guardian of parental authority
- Difficulty of comprehension or communication making the parental information impossible
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 |
|---|---|---|
| Pain measurement during care procedures in neonatal reanimationPain measurement during care procedures in neonatal reanimation | Device | – |
Primary outcome
Variation of the NIPE measures between before and during care.
Time frame: From 10 minutes before the care to 10 minutes after the beginning of the care
Average of NIPE mesures 10 minutes before the begining of the care and 10 minutes after.
3 secondary outcomes
Correlation between the variation of the NIPE measures and the variation of PIPP-R behavioural scale between each period
Time frame: From 10 minutes after the beginning of the care to 10 minutes after the end of the care
Correlation between the NIPEmin and the PIPP-R behavioural scale for each period
Time frame: From 10 minutes before the care to 10 minutes after the care
The discriminant power of the NIPE to split the painful population and the non-painful population determined by a threshold at 6 on the PIPP-R scale
Time frame: From 10 minutes before the care to 10 minutes after the care
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 Apr 2026.
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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.
Riadh Boukris, MD principal investigator
University Hospital, Lille
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 Neonatal and Pain Measurement, run by University Hospital, Lille 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 4 inclusion and 5 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 Apr 2026. 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?
Variation of the NIPE measures between before and during care. (time frame: From 10 minutes before the care to 10 minutes after the beginning of the care). 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 Apr 2026.