## Protocol Section
### Identification Module
**NCT ID:** NCT05827679

**Acronym:** ECAP

**Brief Title:** Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature (ECAP)

**Official Title:** Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature

#### Organization Study ID Info
**ID:** RNI 2022 COLNE
#### Organization
**Class:** OTHER
**Full Name:** University Hospital, Clermont-Ferrand
#### Secondary ID Infos
**Domain:** ANSM
**ID:** 2022-A02779-34
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-09-15

**Type:** ACTUAL

**Last Update Submit Date:** 2023-09-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-09-01

**Type:** ACTUAL

#### Start Date
**Date:** 2023-03-15

**Type:** ACTUAL

**Status Verified Date:** 2023-04

#### Study First Post Date
**Date:** 2023-04-25
**Type:** ACTUAL
**Study First Submit Date:** 2023-03-23
**Study First Submit QC Date:** 2023-04-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Hospital, Clermont-Ferrand

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication.

In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not.

Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage.

To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants.

**Detailed Description:** This is an observational study with longitudinal follow-up regarding the validation of a scale that the investigators have created.

Inclusions will be made when the patient arrives at the Clermont-Ferrand hospital center in the neonatal intensive care units. The patients will be evaluated daily from the 3rd day of life by the nurse, the physiotherapist and the resident of the service. The evaluation will be carried out at least 8 times over 21 days. If an abdominal massage is performed, an assessment of the abdominal condition by the scale will be necessary before and after each massage by the physiotherapist. Each assessment (by physio, nurse and resident) will be blinded and within a maximum time window of 30 minutes.

The first evaluator clears the patient's abdomen (clothing and diaper removed) and then performs the assessment of the abdomen blindly. A description has been written so that each evaluator can use the ECAP scale under the same conditions and with well-detailed judgment criteria in order to have an evaluation that is as reliable as possible.

The time taken to assess the premature baby's abdomen by the ECAP scale is less than 3 minutes. The evaluator fills out the ECAP assessment table, blindly.

Within the next 30 minutes (the patient's abdominal condition is considered stable during this time), the second and third assessors have to do the same.

These assessments are stored together with each patient's clinical data collection, and then analyzed by statisticians.

### Conditions Module

**Conditions:**

- Preterm Birth Complication

- Digestive System Disease

**Keywords:**

- physiotherapy

- abdominal massage

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 120

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** score between 0 and 20

**Measure:** Clinical Abdominal assessment scale for Preterm infant (ECAP scale)

**Time Frame:** up to 18 months

#### Secondary Outcomes

**Description:** score on the Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome)

**Measure:** Indication for abdominal massage on ECAP scale

**Time Frame:** up to 18 months

**Description:** term of birth population

**Measure:** ECAP scale validity

**Time Frame:** up to 18 months

**Description:** variation of the score of Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome)

**Measure:** impact of massage on ECAP scale

**Time Frame:** up to 18 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* newborns, born prematurely (before 37 weeks of amenorrhea)
* at least 3 days of life
* hospitalized in the neonatal intensive care units
* whose holders of parental authority are able to give free and informed consent to participate in this study

Exclusion Criteria:

* Newborns with congenital pathology such as malformation, genetic or chromosomal abnormality.
* Newborns whose holders of parental authority are protected by law (under guardianship) or under the age of 18.
* Rejection of participation by parents

**Maximum Age:** 60 Days

**Minimum Age:** 3 Days

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

**Study Population:** Newborns born before 37 weeks of amenorrhea, hospitalized in the neonatal intensive care units

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Clermont-ferrand

**Country:** France

**Facility:** CHU clermont-ferrand

**Zip:** 63000

#### Overall Officials

**Official 1:**

**Affiliation:** mcolne@chu-clermontferrand.fr

**Name:** Marie COLNÉ

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007752

- Term: Obstetric Labor, Premature

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: HIGH

- As Found: Preterm Birth

- ID: M7255

- Name: Digestive System Diseases

- Relevance: HIGH

- As Found: Digestive System Diseases

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: HIGH

- As Found: Digestive System Diseases

- ID: M10772

- Name: Obstetric Labor, Premature

- Relevance: LOW

- As Found: Unknown

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000047928

- Term: Premature Birth

### Misc Info Module

- Version Holder: 2024-05-24
