Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

NCT06351202 | Recruiting

• 2 other identifiers: RBGP 2023 COLNE2023-A02256-39
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea - WA), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, expressed by abdominal distension, regurgitation, irregular transit and abdominal discomfort. It can influence the length of hospitalization and lead to necrotising enterocolitis, a major complication. At the Clermont-Ferrand University Hospital Center, abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants. The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective. In this context, the investigators carried out a first study to validate a scale that they created (ECAP scale : Clinical Assessment Scale for Abdominal state of Preterm infant) to assess in a rapid, reliable and reproductible manner the abdominal state of preterm infant - data currently being published). This scale can pose the indications for abdominal massage more objectively. The hypothesis is that abdominal massage improves feeding tolerance (decrease ECAP score), allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants. The aim of the study is to assess the effectiveness of abdominal massage, over a period of 14 days, on the feeding tolerance of preterm infants (under 34 weeks of amenorrhea), defined by the achievement and maintenance of an ECAP score less than 4 during 3 days.

Conditions

Preterm Birth Complication; Digestive System Disease

Keywords

physiotherapy; abdominal massage

Outcome Measures

Primary Outcomes (1)

• Clinical Abdominal assessment scale for Preterm infants score (ECAP score)

  score between 0 and 20

  twice day during 14 days

Secondary Outcomes (7)

• Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes

  up to 14 days

• Weight gain of preterm infants with feeding intolerance

  up to 28 days

• Duration to reach the full ration

  up to 28 days

• Duration of hospitalization in level 3

  up to 3 months

• 6-hour fasting windows

  up to 28 days

Study Arms (2)

No abdominal massage group

NO INTERVENTION

During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists.

Abdominal massage group

EXPERIMENTAL

At least 10 abdominal massages will be performed on preterms, by a physiotherapist trained in this technique over a period of 14 days, at the rate of one massage per day.

Other: Abdominal massage

Interventions

Abdominal massage OTHER

An abdominal massage for premature babies lasts 10 minutes. Our abdominal massage techniques is described in our protocole and will be adapted according to the term of the child.

Abdominal massage group

Eligibility Criteria

• Age: 3 Days - 60 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn, premature, less than 34 Weeks of Amennorhea
• at least 3 days of life
• hospitalized in neonatal intensive care units
• with feeding intolerance demonstrated by an ECAP (Clinical Abdominal Assessement scale for preterms) score equal to or greater than 4/20
• whose holders of parental authority are able to give free and informed consent to participate in this study.

You may not qualify if:

• premature newborns with a congenital pathology such as malformation, genetic or chromosomal abnormality
• newborns whose holders of parental authority are protected by law (under guardianship, curatorship, placed under judicial safeguard) or aged under 18
• rejection of participation by parents
• newborns with a contraindication to abdominal massage (fever, major hemodynamic instability)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU clermont-ferrand

Clermont-Ferrand, France

RECRUITING

MeSH Terms

Conditions

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: May 16, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-01

Locations

FR (1)