Actively Recruiting

Phase Not Applicable
Age: 3Days - 60Days
All Genders
NCT06351202

Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

Led by University Hospital, Clermont-Ferrand · Updated on 2024-05-22

120

Participants Needed

1

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

Who Can Participate

Age: 3Days - 60Days
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborn, premature, less than 34 weeks of amenorrhea
  • At least 3 days old
  • Hospitalized in neonatal intensive care units
  • Feeding intolerance shown by an ECAP score of 4 or higher
  • Parents able to provide free and informed consent for participation
Not Eligible

You will not qualify if you...

  • Premature newborns with congenital malformations, genetic, or chromosomal abnormalities
  • Parents under legal protection (guardianship, curatorship, judicial safeguard) or under 18 years old
  • Parents refuse participation
  • Newborns with contraindications to abdominal massage such as fever or major hemodynamic instability

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CHU clermont-ferrand

Clermont-Ferrand, France

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms | DecenTrialz