Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-60
SponsorUniversity Hospital, Clermont-Ferrand

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Abdominal massage

    Other intervention

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: No abdominal massage groupNo intervention 0 interventions
Group B: Abdominal massage groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

score between 0 and 20

Time frame
twice day during 14 days

Secondary outcomes

1

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

score between 0 and 20

Time frame
up to 14 days
2

Weight gain of preterm infants with feeding intolerance

Daily weight of preterm infants, in z-score

Time frame
up to 28 days
3

Duration to reach the full ration

Number of days needed to reach the full ration (120mL/kg/day)

Time frame
up to 28 days
4

Duration of hospitalization in level 3

Total number of days of hospitalization in level 3

Time frame
up to 3 months

Other outcomes

Sponsors and contacts

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