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

NCT05827679 | Completed

• 2 other identifiers: RNI 2022 COLNE2022-A02779-34
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Birth Complication; Digestive System Disease

Keywords

physiotherapy; abdominal massage

Outcome Measures

Primary Outcomes (1)

• Clinical Abdominal assessment scale for Preterm infant (ECAP scale)

  score between 0 and 20

  up to 18 months

Secondary Outcomes (3)

• Indication for abdominal massage on ECAP scale

  up to 18 months

• ECAP scale validity

  up to 18 months

• impact of massage on ECAP scale

  up to 18 months

Eligibility Criteria

• Age: 3 Days - 60 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns born before 37 weeks of amenorrhea, hospitalized in the neonatal intensive care units

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, 63000, France

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Officials

• Marie COLNÉ

  mcolne@chu-clermontferrand.fr

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 25, 2023
• Study Start: March 15, 2023
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-04

Locations

FR (1)