Preterm Birth ComplicationPREMABDONCT06351202
Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms
A study testing Abdominal massage in people with Preterm Birth Complication and Digestive System Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 3 to 60 days
- Conditions the study is for
- Preterm Birth Complication, Digestive System Disease
- What is being tested?
- Abdominal massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU clermont-ferrand
Clermont-Ferrand
Lise LACLAUTRE, 334.73.754.963, llaclautre_perrier@chu-clermontferrand.fr
Marie COLNE
About this study
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
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.
Read more
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.
Read the 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.
- Being tested
- Abdominal massage
- Keywords
- physiotherapy, abdominal massage
- Medical subject headings
- Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal massageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No abdominal massage group | No intervention | During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists. |
| Abdominal massage group | Experimental | 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. Receives: Other: Abdominal massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Abdominal assessment scale for Preterm infants score (ECAP score)
score between 0 and 20
Measured: twice day during 14 days
Secondary outcomes (7)
Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes
score between 0 and 20
Measured: up to 14 days
Weight gain of preterm infants with feeding intolerance
Daily weight of preterm infants, in z-score
Measured: up to 28 days
Duration to reach the full ration
Number of days needed to reach the full ration (120mL/kg/day)
Measured: up to 28 days
Duration of hospitalization in level 3
Total number of days of hospitalization in level 3
Measured: up to 3 months
6-hour fasting windows
Number of 6-hour fasting windows
Measured: up to 28 days
Incidence of occurrence of necrotizing enterocolitis
number of necrotizing enterocolitis
Measured: up to 28 days
Evolution of digestive tolerance over time
Raw ECAP value at t10 minutes over time
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start16 May 2024
- Primary completionFeb 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351202
- Sponsor's protocol ID
- RBGP 2023 COLNE
- Other IDs
- 2023-A02256-39
- Acronym
- PREMABDO
- Status last verified
- Jan 2024
- First submitted
- 2 Apr 2024
- Last updated
- 22 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06351202
- Acronym / sponsor ID
- PREMABDO / RBGP 2023 COLNE
- Keywords
- physiotherapy, abdominal massage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 8 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No abdominal massage group | No intervention | –During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists. |
| Abdominal massage group | Experimental | Other: Abdominal massageAt 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. |
Who may qualify
- Ages
- 3 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal massageAn 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. | Other | Abdominal massage group |
Primary outcome
Clinical Abdominal assessment scale for Preterm infants score (ECAP score)
Time frame: twice day during 14 days
score between 0 and 20
7 secondary outcomes
Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes
Time frame: up to 14 days
Weight gain of preterm infants with feeding intolerance
Time frame: up to 28 days
Duration to reach the full ration
Time frame: up to 28 days
Duration of hospitalization in level 3
Time frame: up to 3 months
6-hour fasting windows
Time frame: up to 28 days
Incidence of occurrence of necrotizing enterocolitis
Time frame: up to 28 days
Evolution of digestive tolerance over time
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal massage in people with Preterm Birth Complication and Digestive System Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Abdominal assessment scale for Preterm infants score (ECAP score) (time frame: twice day during 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2024.