Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04366102
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2020-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064746', 'term': 'Therapy, Soft Tissue'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-03', 'studyFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2020-04-25', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Premature infant pain profile-Revised (PIPP-R)', 'timeFrame': 'Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention', 'description': 'Measuring procedural pain among neonates, having 1 to 3 scoring. 0 describe normal and 3 describes low score'}, {'measure': 'Neonatal pain agitation sedation scale (N-PASS)', 'timeFrame': 'Change score of N-PASS at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention', 'description': 'Measuring procedural pain along with sedation, having score ranged from 0 to 2, 0 describes normal and 2 describes low score'}], 'secondaryOutcomes': [{'measure': 'Infant neurological international battery (INFANIB)', 'timeFrame': 'Change score of INFANIB at the baseline and after five days of intervention', 'description': 'Measuring neurodevelopmental outcomes among preterm neonates. Scoring is from 5, 3, and 1. Score 5 means Normal, score 3 means mildly abnormal, score 1 means markedly abnormal. Total score for preterm neonate is 70.'}, {'measure': 'Premie-Neuro', 'timeFrame': 'Change score of Premie-Neuro at the baseline and after five days of intervention', 'description': 'Premie-neuro used for measuring neurodevelopmental outcome in preterm neonates between 23 and 37 weeks of gestation. It has total 24 items. Each item has a score of 1,3, and 5. Total score is 120. Score less than 70 is considered as abnormal, score between 70-99 is questionable, and score above 100 is normal.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonates', 'Pain'], 'conditions': ['Neonatal Disease', 'Neonatal Disorder']}, 'referencesModule': {'references': [{'pmid': '30026767', 'type': 'BACKGROUND', 'citation': 'Zeraati H, Nasimi F, Rezaeian A, Shahinfar J, Ghorban Zade M. Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial. Iran J Child Neurol. 2018 Summer;12(3):32-39.'}, {'pmid': '25511005', 'type': 'BACKGROUND', 'citation': 'de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.'}, {'pmid': '35385466', 'type': 'DERIVED', 'citation': 'Sharma N, Samuel AJ. Multisensory Stimulation and Soft Tissue Therapy on Pain and Neurodevelopment Among Preterm Neonates. Pediatr Phys Ther. 2022 Apr 1;34(2):277-282. doi: 10.1097/PEP.0000000000000887.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6045934/', 'label': 'Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial'}, {'url': 'https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4311795/', 'label': 'Pain assessment scales in newborns: integrative review'}]}, 'descriptionModule': {'briefSummary': 'To determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the NICU is the aim of the study. The study will be two groups randomized clinical trial of five days intervention program. The intervention will be given among two groups. Group A will receive both multisensory stimulation and soft tissue therapy, Group B will receive only regular hospital care. The PIPP and N-PASS will be used for assessing pain. The INFANIB and Premie-Neuro will be used for assessing neuromotor development among neonates. The outcomes will be taken before and after the fifth day of the intervention. Multisensory stimulation and soft tissue therapy might help in reducing pain and promoting neurodevelopment.', 'detailedDescription': 'This study will utilize two parallel groups, randomised design to analyze the effects of soft tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates admitted in NICU will be recruited through purposive sampling for the trial. Procedural pain will be assessed with PIPP and N-PASS through recorded video. Neurodevelopmental outcomes will be assessed with INFANIB Scale and Premie-Neuro. The measurements will be taken after 24 hours of birth at the baseline and after the fifth day of the intervention. The treatment will be given into two groups i.e. Group A (Multisensory stimulation and soft tissue therapy group), Group B (routine hospital care). MSS will consist of Auditory Stimulation, Tacto-Kinesthetic stimulation, Vestibular stimulation, Visual stimulation, Oral-stimulation, and Olfactive stimulation. Soft tissue therapy consisted of stroking, effleurage, skin rolling, and kneading techniques, Will be given in 5 Phases-Forehead and face, Back and Neck, Chest and abdomen, upper-lower limbs. Total 30 min. of the treatment plan, per day, will be given to the neonates, after 30 min. of feed, for up to 5 days of NICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Days', 'minimumAge': '24 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Preterm between 30- 36 weeks of gestation\n* Birth weight \\>1000 g\n* Not receiving analgesics/sedatives\n* APGAR score ranged between 4-6 in 1 min. \\& 7 to 9 in 5 min.\n* Undergoing routine healthcare procedures in NICU\n\nExclusion Criteria\n\n* Preterm with surgery\n* Preterm having unstable vitals\n* Preterm with congenital malformations\n* Preterm who require mechanical ventilation\n* Having inborn errors of metabolism and also with seizures disorders,'}, 'identificationModule': {'nctId': 'NCT04366102', 'briefTitle': 'Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'Maharishi Markendeswar University (Deemed to be University)'}, 'officialTitle': 'Multisensory Stimulation and Soft Tissue Therapy on Procedural Pain and Neurodevelopment Among Preterm Neonates (MUST-P3) Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MMDU/IEC/2152'}, 'secondaryIdInfos': [{'id': 'U1111-1242-9663', 'type': 'OTHER', 'domain': 'Universal Trial Number (UTN)-WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Multisensory stimulation and soft tissue therapy', 'interventionNames': ['Other: Multisensory stimulation with soft tissue therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Routine Hospital care', 'interventionNames': ['Other: Routine hospital care']}], 'interventions': [{'name': 'Multisensory stimulation with soft tissue therapy', 'type': 'OTHER', 'description': 'Multisensory stimulation with soft tissue therapy will be given. Multisensory stimulation consists of Auditory, vestibular, tactile, olfactive, oromotor, Visual, and Kinesthetic stimulation. Soft tissue therapy consists of stroking, effleurage, fingertip kneading, tapping, and skin rolling will be given. Total intervention will be given for 30 min. 5 times per week', 'armGroupLabels': ['Group A']}, {'name': 'Routine hospital care', 'type': 'OTHER', 'description': 'Routine hospital care will be given to the preterm neonates', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133207', 'city': 'Ambāla', 'state': 'Haryana', 'country': 'India', 'facility': 'Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital', 'geoPoint': {'lat': 30.36099, 'lon': 76.79782}}], 'overallOfficials': [{'name': 'Neha Sharma, MPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation'}, {'name': 'Asir J Samuel, MPT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation'}, {'name': 'Kusum Mahajan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Maharishi Markandeshwar Institute of Medical Sciences & Research'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Study Protocol - December, 2020 Statistical Analysis Plan (SAP) - December, 2020 Informed Consent Form (ICF) - December, 2020', 'ipdSharing': 'YES', 'description': 'Individual participant data (IPD) will be shared via Mendeley Dataset', 'accessCriteria': 'By publishing study protocol with detailed statistical Analysis Plan in SCOPUS and PubMed indexed journals'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asir John Samuel', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of Science and Technology, Government of India', 'class': 'UNKNOWN'}, {'name': 'Maharishi Markendeswar University (Deemed to be University)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Asir John Samuel', 'investigatorAffiliation': 'Maharishi Markendeswar University (Deemed to be University)'}}}}