Extremely Premature InfantDOU-PREMANCT07481331
Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Discomfort Scale (EDIN)
An observational study of Extremely Premature Infant and Pain, run by Centre Hospitalier Universitaire de la Réunion.
Trial summary
The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which will be called the EDEX (Extremely Premature Infant Pain Assessment Scale). Read more about this study
- Who is it for?
- Ages Up to 27 weeks
- Conditions the study is for
- Extremely Premature Infant, Pain, Discomfort Symptoms
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 27 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Extremely premature infants(< 27 weeks of amenorrhea) hospitalised in neonatal intensive care at University Hospital Centre of Reunion Island
Who may be able to join
- Extremely premature infants:
- born before 27 weeks of gestation, and aged no more than 26 weeks of amenorrhea + 6 days in corrected age,
- from 48 hours of life,
- hospitalised in neonatal intensive care,
- for whom at least one of the two legal guardians has given their consent.
Who cannot join
- Extreme premature infants:
- whose clinical condition is critical with a risk of imminent death,
- with major brain damage (HIV 4) or major brain malformations,
- deeply sedated or paralyzed with no spontaneous reactions,
- whose parents are both minors.
- who are not already participating in another study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Distress Scale (EDIN)
The goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which will be called the EDEX (Extremely Premature Infant Pain Assessment Scale).
This scale will take into account the level of development of extremely premature infants, recognizing that the perception and manifestations of pain vary according to gestational age.
Read more
It was chosen to develop a specific pain assessment scale for preterm infants born before 27 weeks of gestation, in line with their level of development and their relatively homogeneous manifestations in this population.
This population, which is the most immature, is particularly fragile and sensitive to its environment and the care provided. Pain manifestations are the most subtle, vegetative reactions are very present, and the motor system is still underdeveloped, linked to low muscle tone.
It is with this category of patients that the nursing staff encounter the most difficulty in assessing pain and discomfort based on the EDIN scale.
After creating the new EDEX scale during the first phase of the DOU-PREMA study, both scales (EDIN and EDEX) will be administered to the same pool of extremely premature infants during the second phase of the DOU-PRÉMA study in order to assess the correlation between the two scales.
The main hypothesis is that EDIN and EDEX scores will not be correlated, as the EDIN does not appear to be suitable for extremely premature infants in routine practice.
if the hypothesis is confirmed, a multicenter psychometric validation of the EDEX scale will then be considered in a future study.
The study is a monocentric, non-interventional observational study conducted in the neonatal intensive care unit (NICU) of the University Hospital of Reunion Island (Site Nord). It is designed as a preliminary step toward the psychometric validation of a newly developed behavioral pain and discomfort assessment scale for extremely preterm infants (<27 weeks' gestational age), named EDEX.
The study includes two sequential phases:
- a developmental phase dedicated to the creation of the EDEX scale : This stage is based on the production of videos of premature extreme in order to ajust the provisional scale define during a multidisciplinary meeting.
- a cross-sectional observational phase comparing EDEX with the EDIN scale in the same population.
The second phase of the project will evaluate the correlation between EDIN and EDEX scores.
This protocol follows the SPIRIT recommendations for study protocols involving human participants.
- Conditions
- Extremely Premature Infant, Pain, Discomfort Symptoms
- Keywords
- pain and discomfort scale, extremely premature infants
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| EP - phase 1 | Production of observation videos at 8 Extremely Premature infants | |
| EP - Phase 2 | Assessment of pain and discomfort in 60 extremely premature infants using EDIN and EDEX scales |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between scores on the new EDEX pain assessment scale and scores obtained with the EDIN
The correlation between EDIN and EDEX scores will be assessed using Spearman's coefficient.
Measured: at baseline
Secondary outcomes (5)
Distribution of scores obtained in the EDIN and EDEX
The position and dispersion indicators for each distribution will be calculated (mean, median, standard deviation, etc.).
Measured: through study completion, an average of 18 months
Description of the EDEX adaptation procedure.
The following will be described: the number of meetings required, the time needed for multidisciplinary reflection at each stage, the need for arbitration, the main stages in the construction of the new tool, and the differences compared to EDIN.
Measured: through study completion, an average of 18 months
Description of the difficulties and quality of the EDEX adaptation, by the members of the working group
5 questions on satisfaction with the quality of the process of creating the new scale, each rated from 0 to 100, and 25 questions on the difficulty of adapting each item, each rated from 0 to 100.
Measured: through study completion, an average of 18 months
Assessment of paramedics' satisfaction with EDEX
10 closed questions and one open question. The response options for closed questions are in the form of a 5-point or 4-point Likert scale for 2 questions.
Measured: through study completion, an average of 18 months
Comparison of EDIN and EDEX scores before and after taking painkillers (sensitivity to change)
Scores measured before taking any painkillers and after taking painkillers for the first time will be considered.
Measured: through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extremely Premature InfantStudies of the same condition, open and under way.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fleur BRIGNANO, Principal investigator, University Hospital Centre of Reunion Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481331
- Sponsor's protocol ID
- 2025/CHU/17
- Acronym
- DOU-PREMA
- Status last verified
- Sep 2026
- First submitted
- 9 Mar 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Scale for Assessing Pain and Discomfort in Extremely Premature Infants (EDEX) Hospitalised in Neonatal Intensive Care, Inspired by the Early Infant Pain and Distress Scale (EDIN)
- ClinicalTrials.gov ID
- NCT07481331
- Acronym / sponsor ID
- DOU-PREMA / 2025/CHU/17
- Conditions
- Extremely Premature Infant, Pain, Discomfort Symptoms
- Keywords
- pain and discomfort scale, extremely premature infants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Mar 2026 (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 goal of this study is to develop a new scale for assessing prolonged pain, dedicated to extremely premature infants born before 27 weeks of gestation, adapted to their particular ways of expressing pain and discomfort, which will be called the EDEX (Extremely Premature Infant Pain Assessment Scale).
This scale will take into account the level of development of extremely premature infants, recognizing that the perception and manifestations of pain vary according to gestational age.
It was chosen to develop a specific pain assessment scale for preterm infants born before 27 weeks of gestation, in line with their level of development and their relatively homogeneous manifestations in this population.
This population, which is the most immature, is particularly fragile and sensitive to its environment and the care provided. Pain manifestations are the most subtle, vegetative reactions are very present, and the motor system is still underdeveloped, linked to low muscle tone.
It is with this category of patients that the nursing staff encounter the most difficulty in assessing pain and discomfort based on the EDIN scale.
After creating the new EDEX scale during the first phase of the DOU-PREMA study, both scales (EDIN and EDEX) will be administered to the same pool of extremely premature infants during the second phase of the DOU-PRÉMA study in order to assess the correlation between the two scales.
The main hypothesis is that EDIN and EDEX scores will not be correlated, as the EDIN does not appear to be suitable for extremely premature infants in routine practice.
if the hypothesis is confirmed, a multicenter psychometric validation of the EDEX scale will then be considered in a future study.
The study is a monocentric, non-interventional observational study conducted in the neonatal intensive care unit (NICU) of the University Hospital of Reunion Island (Site Nord). It is designed as a preliminary step toward the psychometric validation of a newly developed behavioral pain and discomfort assessment scale for extremely preterm infants (<27 weeks' gestational age), named EDEX.
The study includes two sequential phases:
- a developmental phase dedicated to the creation of the EDEX scale : This stage is based on the production of videos of premature extreme in order to ajust the provisional scale define during a multidisciplinary meeting.
- a cross-sectional observational phase comparing EDEX with the EDIN scale in the same population.
The second phase of the project will evaluate the correlation between EDIN and EDEX scores.
This protocol follows the SPIRIT recommendations for study protocols involving human participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP - phase 1 | – | –Production of observation videos at 8 Extremely Premature infants |
| EP - Phase 2 | – | –Assessment of pain and discomfort in 60 extremely premature infants using EDIN and EDEX scales |
Who may qualify
- Ages
- Up to 27 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely premature infants(< 27 weeks of amenorrhea) hospitalised in neonatal intensive care at University Hospital Centre of Reunion Island
Key inclusion criteria (5 listed)
- born before 27 weeks of gestation, and aged no more than 26 weeks of amenorrhea + 6 days in corrected age,
- from 48 hours of life,
- hospitalised in neonatal intensive care,
- for whom at least one of the two legal guardians has given their consent.
Key exclusion criteria (6 listed)
- whose clinical condition is critical with a risk of imminent death,
- with major brain damage (HIV 4) or major brain malformations,
- deeply sedated or paralyzed with no spontaneous reactions,
- whose parents are both minors.
- who are not already participating in another study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between scores on the new EDEX pain assessment scale and scores obtained with the EDIN
Time frame: at baseline
The correlation between EDIN and EDEX scores will be assessed using Spearman's coefficient.
5 secondary outcomes
Distribution of scores obtained in the EDIN and EDEX
Time frame: through study completion, an average of 18 months
Description of the EDEX adaptation procedure.
Time frame: through study completion, an average of 18 months
Description of the difficulties and quality of the EDEX adaptation, by the members of the working group
Time frame: through study completion, an average of 18 months
Assessment of paramedics' satisfaction with EDEX
Time frame: through study completion, an average of 18 months
Comparison of EDIN and EDEX scores before and after taking painkillers (sensitivity to change)
Time frame: through study completion, an average of 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- 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.
Fleur BRIGNANO principal investigator
University Hospital Centre of Reunion Island
Questions about this trial
What is this clinical trial studying?
An observational study of Extremely Premature Infant and Pain, run by Centre Hospitalier Universitaire de la Réunion.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fleur BRIGNANO (+262692295999, fleur.brignano@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between scores on the new EDEX pain assessment scale and scores obtained with the EDIN (time frame: at baseline). 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 11 Sep 2026.