About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Abdominal massage
Other interventionAn 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.
Treatment groups
Trial outcomes
Primary outcomes
Clinical Abdominal assessment scale for Preterm infants score (ECAP score)
score between 0 and 20
Secondary outcomes
Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes
score between 0 and 20
Weight gain of preterm infants with feeding intolerance
Daily weight of preterm infants, in z-score
Duration to reach the full ration
Number of days needed to reach the full ration (120mL/kg/day)
Duration of hospitalization in level 3
Total number of days of hospitalization in level 3
Sponsors and contacts
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