Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms (PREMABDO)

Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled 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.

Study Overview

• Status: Recruiting
• Conditions: Digestive System Disease; Preterm Birth Complication
• Intervention / Treatment: Other: Abdominal massage

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Marie COLNE
    • Contact: Lise LACLAUTRE; Phone Number: 334.73.754.963; Email: llaclautre_perrier@chu-clermontferrand.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No abdominal massage group; During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists.
Experimental: Abdominal massage group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Abdominal assessment scale for Preterm infants score (ECAP score)	score between 0 and 20	twice day during 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes	score between 0 and 20	up to 14 days
Weight gain of preterm infants with feeding intolerance	Daily weight of preterm infants, in z-score	up to 28 days
Duration to reach the full ration	Number of days needed to reach the full ration (120mL/kg/day)	up to 28 days
Duration of hospitalization in level 3	Total number of days of hospitalization in level 3	up to 3 months
6-hour fasting windows	Number of 6-hour fasting windows	up to 28 days
Incidence of occurrence of necrotizing enterocolitis	number of necrotizing enterocolitis	up to 28 days
Evolution of digestive tolerance over time	Raw ECAP value at t10 minutes over time	up to 28 days

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2024
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: physiotherapy; abdominal massage
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: RBGP 2023 COLNE; 2023-A02256-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No