Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms

Digestive System Disease Clinical Trial

— PREMABDO  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06351202
• Other study ID #: RBGP 2023 COLNE
• Secondary ID: 2023-A02256-39
• Status: Recruiting
• Phase: N/A
• Start date: May 16, 2024
• Est. completion date: June 2026

Study information

• Verified date: January 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Days to 60 Days

Eligibility

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)

Related Conditions & MeSH terms

• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases
• Premature Birth
• Preterm Birth Complication

Intervention

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.

Locations

Country	Name	City	State
France	CHU clermont-ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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