Preterm Birth ComplicationECAPNCT05827679
Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature (ECAP)
An observational study of 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), and present an immaturity of their various systems, in particular the digestive system. 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
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2023to 1 Sep 2023
- Phase
- Observational
- 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
- Child
Study population: Newborns born before 37 weeks of amenorrhea, hospitalized in the neonatal intensive care units
Who may be able to join
- newborns, born prematurely (before 37 weeks of amenorrhea)
- at least 3 days of life
- hospitalized in the neonatal intensive care units
- whose holders of parental authority are able to give free and informed consent to participate in this study
Who cannot join
- Newborns with congenital pathology such as malformation, genetic or chromosomal abnormality.
- Newborns whose holders of parental authority are protected by law (under guardianship) or under the age of 18.
- Rejection of participation by parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature
Every year in France, 60,000 children are born prematurely (before 37 weeks of amenorrhea), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication.
In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not.
Read more
Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage.
To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants.
Read the detailed description
This is an observational study with longitudinal follow-up regarding the validation of a scale that the investigators have created.
Inclusions will be made when the patient arrives at the Clermont-Ferrand hospital center in the neonatal intensive care units. The patients will be evaluated daily from the 3rd day of life by the nurse, the physiotherapist and the resident of the service. The evaluation will be carried out at least 8 times over 21 days. If an abdominal massage is performed, an assessment of the abdominal condition by the scale will be necessary before and after each massage by the physiotherapist. Each assessment (by physio, nurse and resident) will be blinded and within a maximum time window of 30 minutes.
The first evaluator clears the patient's abdomen (clothing and diaper removed) and then performs the assessment of the abdomen blindly. A description has been written so that each evaluator can use the ECAP scale under the same conditions and with well-detailed judgment criteria in order to have an evaluation that is as reliable as possible.
The time taken to assess the premature baby's abdomen by the ECAP scale is less than 3 minutes. The evaluator fills out the ECAP assessment table, blindly.
Within the next 30 minutes (the patient's abdominal condition is considered stable during this time), the second and third assessors have to do the same.
These assessments are stored together with each patient's clinical data collection, and then analyzed by statisticians.
- Keywords
- physiotherapy, abdominal massage
- Medical subject headings
- Digestive System Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Abdominal assessment scale for Preterm infant (ECAP scale)
score between 0 and 20
Measured: up to 18 months
Secondary outcomes (3)
Indication for abdominal massage on ECAP scale
score on the Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome)
Measured: up to 18 months
ECAP scale validity
term of birth population
Measured: up to 18 months
impact of massage on ECAP scale
variation of the score of Clinical Abdominal assessment scale for Preterm infants, between 0 and 20 (higher scores meaning worse outcome)
Measured: up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start15 Mar 2023
- Primary completion1 Sep 2023
- Study completion1 Sep 2023
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie COLNÉ, Principal investigator, mcolne@chu-clermontferrand.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827679
- Sponsor's protocol ID
- RNI 2022 COLNE
- Other IDs
- 2022-A02779-34
- Acronym
- ECAP
- Status last verified
- Apr 2023
- First submitted
- 23 Mar 2023
- Last updated
- 15 Sep 2023
- 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 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation and Validation of a Clinical Evaluation Scale for Abdominal Condition of the Premature
- ClinicalTrials.gov ID
- NCT05827679
- Acronym / sponsor ID
- ECAP / RNI 2022 COLNE
- Keywords
- physiotherapy, abdominal massage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Apr 2023 (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), and present an immaturity of their various systems, in particular the digestive system. This can result in feeding intolerance, which is expressed by abdominal distension, regurgitation or vomiting, irregular transit and abdominal discomfort. This feeding intolerance influences the length of hospitalization and can lead to necrotising enterocolitis, a major complication.
In the Neonatal Intensive Care Units of Clermont-Ferrand hospital center, abdominal massages have been performed by physiotherapists for several years in order to improve the condition of the digestive system. However, the indication for abdominal massage is very dependent on the caregivers in charge of the newborn and the evaluation of the abdominal condition remains subjective with a great variability between examiners. Thus, some newborns will receive massage multiple times a day while others will not.
Developmental care is essential for these premature infants, especially to avoid over-stimulation. It is important not to add care, such as massage, if it is not needed. It is therefore essential to properly assess the digestive status of premature babies in order to determine whether they have feeding intolerance and whether they require treatment with abdominal massage.
To date, the investigators have not found measurable criteria or existing scales that can describe the digestive status of newborns. The main objective of the study is therefore to create and validate a clinical assessment scale for the abdominal status of preterm infants.
Detailed description
This is an observational study with longitudinal follow-up regarding the validation of a scale that the investigators have created.
Inclusions will be made when the patient arrives at the Clermont-Ferrand hospital center in the neonatal intensive care units. The patients will be evaluated daily from the 3rd day of life by the nurse, the physiotherapist and the resident of the service. The evaluation will be carried out at least 8 times over 21 days. If an abdominal massage is performed, an assessment of the abdominal condition by the scale will be necessary before and after each massage by the physiotherapist. Each assessment (by physio, nurse and resident) will be blinded and within a maximum time window of 30 minutes.
The first evaluator clears the patient's abdomen (clothing and diaper removed) and then performs the assessment of the abdomen blindly. A description has been written so that each evaluator can use the ECAP scale under the same conditions and with well-detailed judgment criteria in order to have an evaluation that is as reliable as possible.
The time taken to assess the premature baby's abdomen by the ECAP scale is less than 3 minutes. The evaluator fills out the ECAP assessment table, blindly.
Within the next 30 minutes (the patient's abdominal condition is considered stable during this time), the second and third assessors have to do the same.
These assessments are stored together with each patient's clinical data collection, and then analyzed by statisticians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 60 days
- Sex
- All
- Age groups
- Child
- Study population
- Newborns born before 37 weeks of amenorrhea, hospitalized in the neonatal intensive care units
Key inclusion criteria (4 listed)
- newborns, born prematurely (before 37 weeks of amenorrhea)
- at least 3 days of life
- hospitalized in the neonatal intensive care units
- whose holders of parental authority are able to give free and informed consent to participate in this study
Key exclusion criteria (3 listed)
- Newborns with congenital pathology such as malformation, genetic or chromosomal abnormality.
- Newborns whose holders of parental authority are protected by law (under guardianship) or under the age of 18.
- Rejection of participation by parents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Abdominal assessment scale for Preterm infant (ECAP scale)
Time frame: up to 18 months
score between 0 and 20
3 secondary outcomes
Indication for abdominal massage on ECAP scale
Time frame: up to 18 months
ECAP scale validity
Time frame: up to 18 months
impact of massage on ECAP scale
Time frame: up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
Related trials for Preterm Birth Complication
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Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Marie COLNÉ principal investigator
mcolne@chu-clermontferrand.fr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 15 Sep 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Abdominal assessment scale for Preterm infant (ECAP scale) (time frame: up to 18 months). 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 15 Sep 2023.