Actively Recruiting
Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial
Led by University Hospital, Clermont-Ferrand · Updated on 2024-05-22
120
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Premature infants born before 34 weeks of amenorrhea often face digestive system immaturity, leading to feeding intolerance marked by symptoms like abdominal distension and discomfort. This can affect hospital stay length and risk serious complications such as necrotizing enterocolitis. Researchers are evaluating whether abdominal massage can improve feeding tolerance, promote faster weight gain, and shorten hospitalization in these preterm infants using a validated clinical scale called ECAP. In this single-blind, randomized controlled trial, preterm infants with feeding intolerance will be assigned to one of two groups. One group will receive no abdominal massage, while the other group will receive at least 10 daily abdominal massages performed by trained physiotherapists over a 14-day period. The massage lasts about 10 minutes and is adjusted according to the infant's gestational age. Throughout the study, the ECAP score assessing abdominal state will be measured twice daily before and after massage. Secondary measures include weight gain, time to reach full feeding ration, hospitalization duration, fasting periods, incidence of necrotizing enterocolitis, and digestive tolerance changes over up to 28 days. The study lasts up to 3 months to monitor hospitalization outcomes, with all assessments conducted in neonatal intensive care units.
CONDITIONS
Brief Title
Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newborn premature infants less than 34 weeks of amenorrhea
- At least 3 days old
- Hospitalized in neonatal intensive care units
- Feeding intolerance with ECAP score of 4 or higher
- Parental authority holders able to give informed consent
You will not qualify if you...
- Premature newborns with congenital malformations, genetic or chromosomal abnormalities
- Newborns whose parents or guardians are legally protected or under 18 years old
- Parents refuse participation
- Newborns with contraindications to abdominal massage such as fever or major hemodynamic instability
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 days
Participants receive either daily abdominal massage performed by a trained physiotherapist or no massage for 14 days to assess feeding tolerance.
Daily visits for up to 14 days
Trial Site Locations
Total: 1 location
1
CHU clermont-ferrand
Clermont-Ferrand, France
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here