Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT06351202
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-21', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Abdominal assessment scale for Preterm infants score (ECAP score)', 'timeFrame': 'twice day during 14 days', 'description': 'score between 0 and 20'}], 'secondaryOutcomes': [{'measure': 'Variation of the ECAP score (Clinical Abdominal assessement scale for preterms score) between t0 minute and t10 minutes', 'timeFrame': 'up to 14 days', 'description': 'score between 0 and 20'}, {'measure': 'Weight gain of preterm infants with feeding intolerance', 'timeFrame': 'up to 28 days', 'description': 'Daily weight of preterm infants, in z-score'}, {'measure': 'Duration to reach the full ration', 'timeFrame': 'up to 28 days', 'description': 'Number of days needed to reach the full ration (120mL/kg/day)'}, {'measure': 'Duration of hospitalization in level 3', 'timeFrame': 'up to 3 months', 'description': 'Total number of days of hospitalization in level 3'}, {'measure': '6-hour fasting windows', 'timeFrame': 'up to 28 days', 'description': 'Number of 6-hour fasting windows'}, {'measure': 'Incidence of occurrence of necrotizing enterocolitis', 'timeFrame': 'up to 28 days', 'description': 'number of necrotizing enterocolitis'}, {'measure': 'Evolution of digestive tolerance over time', 'timeFrame': 'up to 28 days', 'description': 'Raw ECAP value at t10 minutes over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['physiotherapy', 'abdominal massage'], 'conditions': ['Preterm Birth Complication', 'Digestive System Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nAt 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.\n\nIn 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.\n\nThe 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.\n\nThe 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.', 'detailedDescription': "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).\n\nAn 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.\n\nAfter obtaining the signed consents, the randomization will follow. In the first group, preterm infants with feeding intolerance will not be massed.\n\nIn 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.\n\nEach 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newborn, premature, less than 34 Weeks of Amennorhea\n* at least 3 days of life\n* hospitalized in neonatal intensive care units\n* with feeding intolerance demonstrated by an ECAP (Clinical Abdominal Assessement scale for preterms) score equal to or greater than 4/20\n* whose holders of parental authority are able to give free and informed consent to participate in this study.\n\nExclusion Criteria:\n\n* premature newborns with a congenital pathology such as malformation, genetic or chromosomal abnormality\n* newborns whose holders of parental authority are protected by law (under guardianship, curatorship, placed under judicial safeguard) or aged under 18\n* rejection of participation by parents\n* newborns with a contraindication to abdominal massage (fever, major hemodynamic instability)'}, 'identificationModule': {'nctId': 'NCT06351202', 'acronym': 'PREMABDO', 'briefTitle': 'Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms (Less Than 34 Weeks of Amenorrhea) : a Randomized, Single-blind Controlled Trial', 'orgStudyIdInfo': {'id': 'RBGP 2023 COLNE'}, 'secondaryIdInfos': [{'id': '2023-A02256-39', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No abdominal massage group', 'description': 'During 14 days, preterm infants with feeding intolerance will not be massed by physiotherapists.'}, {'type': 'EXPERIMENTAL', 'label': 'Abdominal massage group', 'description': '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.', 'interventionNames': ['Other: Abdominal massage']}], 'interventions': [{'name': 'Abdominal massage', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Abdominal massage group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Lise LACLAUTRE', 'role': 'CONTACT', 'email': 'llaclautre_perrier@chu-clermontferrand.fr', 'phone': '334.73.754.963'}, {'name': 'Marie COLNE', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU clermont-ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}