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) (DOU-PREMA)

March 16, 2026 updated by: Centre Hospitalier Universitaire de la Réunion

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.

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:

  1. 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.
  2. 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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Extremely premature infants(< 27 weeks of amenorrhea) hospitalised in neonatal intensive care at University Hospital Centre of Reunion Island

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of scores obtained in the EDIN and EDEX
Time Frame: through study completion, an average of 18 months
The position and dispersion indicators for each distribution will be calculated (mean, median, standard deviation, etc.).
through study completion, an average of 18 months
Description of the EDEX adaptation procedure.
Time Frame: through study completion, an average of 18 months
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.
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
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.
through study completion, an average of 18 months
Assessment of paramedics' satisfaction with EDEX
Time Frame: through study completion, an average of 18 months
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.
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
Scores measured before taking any painkillers and after taking painkillers for the first time will be considered.
through study completion, an average of 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Investigators

  • Principal Investigator: Fleur BRIGNANO, University Hospital Centre of Reunion Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025/CHU/17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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