Ignite Creation Date:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-31 @ 9:45 PM
Study NCT ID:
NCT06706128
Status:
COMPLETED
Last Update Posted:
2024-11-26
First Post:
2024-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-23', 'studyFirstSubmitDate': '2024-11-23', 'studyFirstSubmitQcDate': '2024-11-23', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory Rate', 'timeFrame': 'Respiratory Rate measured at day (0) at after 2 weeks', 'description': 'Detected using monitors (Hunt Leigh Healthcare /United Kingdom).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pneumonia']}, 'descriptionModule': {'briefSummary': 'Respiratory problems in neonates are one of the leading causes of neonatal morbidity and mortality in developing countries. These respiratory problems are seen in premature neonates, which mainly include respiratory distress syndrome (RDS), pneumonia, requiring ventilatory assistance or oxygen support', 'detailedDescription': 'The purpose of this study is to compare between the effect of reflex rolling and lung squeezing techniques on pulmonary functions in premature neonates with pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'minimumAge': '5 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\) Preterm neonates with pneumonia. 2) Neonates with 30-37 weeks of gestation admitted to NICU. 3) They were free from any major congenital malformation. 4) They were clinically and thermodynamically stable.\n\nExclusion Criteria:\n\n* 1\\) Treatment with neurotropic drugs. 2) Interventricular hemorrhage. 3) Temperature \\>38 4) Respiratory and cardiac congenital anomalies. 5) Seizures. 6) Surgical procedures. 7) Genetic Disorders 8) Any segmental or lobar collapse confirmed on chest x-ray. 9) Major airway interventions including change of endo-tracheal tube, hand ventilation or bronchial lavage in the previous 12 hours.'}, 'identificationModule': {'nctId': 'NCT06706128', 'briefTitle': 'Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia', 'organization': {'class': 'OTHER', 'fullName': 'Delta University for Science and Technology'}, 'officialTitle': 'Reflex Rolling Versus Lung Squeezing Techniques On Pulmonary Functions In Premature Neonate With Pneumonia', 'orgStudyIdInfo': {'id': 'Pneumonia.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A)', 'description': 'Consisted of twelve Preterm neonates', 'interventionNames': ['Other: reflex rolling technique']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (B)', 'description': 'Consisted of twelve Preterm neonates', 'interventionNames': ['Other: lung squeezing technique']}], 'interventions': [{'name': 'reflex rolling technique', 'type': 'OTHER', 'description': 'received reflex rolling technique for 20 min, 5 days a week, for 2 weeks.', 'armGroupLabels': ['Group (A)']}, {'name': 'lung squeezing technique', 'type': 'OTHER', 'description': 'lung squeezing technique for 20 min, 5 days a week, for 2 weeks', 'armGroupLabels': ['Group (B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35712', 'city': 'Gamasa', 'state': 'Dakahelia', 'country': 'Egypt', 'facility': 'Delta University for Science and Technology', 'geoPoint': {'lat': 31.44112, 'lon': 31.53675}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Delta University for Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}