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NCT Number: NCT07481331

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)

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.

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Key information

Conditions

Extremely Premature Infant Discomfort Symptoms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 27 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fleur BRIGNANO

CONTACT

[email protected]

+262692295999

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de la Réunion

Other

Registry information

Official study 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)

Acronym: DOU-PREMA

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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