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)

NCT07481331 | Not Yet Recruiting

• 1 other identifier: 2025/CHU/17
• Study Type: observational
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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). 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. 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. 2.a cross-sectional observational phase comparing EDEX with the EDIN scale in the same population.

Conditions

Extremely Premature Infant; Pain; Discomfort Symptoms

Keywords

pain and discomfort scale; extremely premature infants

Outcome Measures

Primary Outcomes (1)

• 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.

  at baseline

Secondary Outcomes (5)

• Distribution of scores obtained in the EDIN and EDEX

  through study completion, an average of 18 months

• Description of the EDEX adaptation procedure.

  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

  through study completion, an average of 18 months

• Assessment of paramedics' satisfaction with EDEX

  through study completion, an average of 18 months

• Comparison of EDIN and EDEX scores before and after taking painkillers (sensitivity to change)

  through study completion, an average of 18 months

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 27 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Fleur BRIGNANO

  University Hospital Centre of Reunion Island

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fleur BRIGNANO

CONTACT

+262692295999; fleur.brignano@chu-reunion.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share