Assessing the effects of abdominal massage on feeding tolerance in preterm infants
Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial
NA · University Hospital, Clermont-Ferrand · NCT06351202
This study is testing if giving daily abdominal massages to preterm infants in the hospital can help them tolerate feeding better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 3 Days to 60 Days |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand (other) |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06351202 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of abdominal massage on feeding tolerance in preterm infants hospitalized in neonatal intensive care units. The study involves a single-blind, randomized controlled design where infants with feeding intolerance will be divided into two groups: one receiving daily abdominal massages from trained physiotherapists and the other not receiving any massages. The effectiveness of the intervention will be assessed using a newly developed Clinical Assessment Scale for Abdominal state of Preterm infants (ECAP). The goal is to determine if abdominal massage can improve digestive function and reduce complications associated with feeding intolerance.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born before 34 weeks of amenorrhea who are experiencing feeding intolerance.
Not a fit: Patients with congenital pathologies, severe hemodynamic instability, or contraindications to abdominal massage will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance feeding tolerance in preterm infants, potentially reducing hospitalization time and the risk of severe complications.
How similar studies have performed: While this approach is innovative, previous studies have shown promising results with similar physiotherapy techniques in improving outcomes for preterm infants.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Clermont-Ferrand
- CHU clermont-ferrand — Clermont-Ferrand, France (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth Complication, Digestive System Disease, physiotherapy, abdominal massage