Clinical trial NCT06351202: Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms
Official title: Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Preterm Birth Complication
Digestive System Disease
Keywords: physiotherapy
abdominal massage
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: This is a single-blind, randomized controlled study. The children will be recruited in the Neonatal Intensive Care Units of the investigation center, by the nursing staff carrying out the ECAP assessment (physiotherapists, nurses, doctors).

An information note will be presented and explained by an element of the medical or paramedical staff to the parents. After a 24 hours reflexion period and answer to any questions they may have, written and informed consent will be requested from both parents for their child's participation in this study.

After obtaining the signed consents, the randomization will follow. In the first group, preterm infants with feeding intolerance will not be massed.

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

Each day, the ECAP assessment will be performed at t0min (just before performing an abdominal massage in the massed group) and at t10min (just after performing the massage). The investigators estimate that an abdominal massage for premature babies lasts 10 minutes. The abdominal massage techniques will be adapted according to the term of the child.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Clinical Abdominal assessment scale for Preterm infants score (ECAP score)
timeFrame: twice day during 14 days
Secondary outcomes:
measure: Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes
timeFrame: up to 14 days
measure: Weight gain of preterm infants with feeding intolerance
timeFrame: up to 28 days
measure: Duration to reach the full ration
timeFrame: up to 28 days
measure: Duration of hospitalization in level 3
timeFrame: up to 3 months
measure: 6-hour fasting windows
timeFrame: up to 28 days
measure: Incidence of occurrence of necrotizing enterocolitis
timeFrame: up to 28 days
measure: Evolution of digestive tolerance over time
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
References: