Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2026-03-04 @ 10:25 PM
Study NCT ID:
NCT00947518
Status:
COMPLETED
Last Update Posted:
2018-06-25
First Post:
2009-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D012871', 'term': 'Skin Diseases'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002710', 'term': 'Chlorhexidine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeevasankar@gmail.com', 'phone': '+91-11-26594372', 'title': 'Mari Jeeva Sankar', 'organization': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'OG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'OG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.99', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'statisticalMethod': 'Kruskal-Wallis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEDIAN', 'timeFrame': 'At 24 hours', 'description': 'The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Skin Temperature at 30 Min After Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'OG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'OG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}], 'classes': [{'categories': [{'measurements': [{'value': '36.6', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '36.6', 'spread': '0.12', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '0.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.46', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at 30 min after intervention', 'description': 'Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes', 'unitOfMeasure': 'Degree Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Positive Skin Culture at Axilla', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'OG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'OG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': '24 hours after intervention', 'description': 'Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Clinical and Culture Positive Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'OG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'OG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}], 'classes': [{'title': 'Culture-positive sepsis', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Clinical sepsis', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY', 'otherAnalysisDescription': "For comparison of categorical variables among the three groups, Chi2 test followed by Bonferroni's correction was used."}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'First week of life', 'description': 'Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'FG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'FG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'from August 2005 to February 2006 at the tertiary level neonatal intensive care unit of All India Institute of Medical Sciences, New Delhi', 'preAssignmentDetails': 'Infants with one minute Apgar score \\<4, hemodynamic instability, congenital malformations, generalized skin disorder and who needed respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) were excluded'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorhexidine Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)'}, {'id': 'BG001', 'title': 'Saline Skin Cleansing', 'description': 'Wiping the skin (except the face) using baby wipes containing normal saline'}, {'id': 'BG002', 'title': 'No Skin Cleansing', 'description': 'No skin application'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestation (weeks)', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '36'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '36'}, {'value': '32.5', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '36'}, {'value': '33', 'groupId': 'BG003', 'lowerLimit': '28', 'upperLimit': '36'}]}]}], 'paramType': 'MEDIAN', 'description': 'Estimated gestational age in completed weeks', 'unitOfMeasure': 'weeks', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-19', 'studyFirstSubmitDate': '2009-04-20', 'resultsFirstSubmitDate': '2009-04-20', 'studyFirstSubmitQcDate': '2009-07-27', 'lastUpdatePostDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-07-27', 'studyFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-07-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Skin Condition Score on the 9-point Skin Condition Grading Scale Adapted by Darmstadt From Lane et al', 'timeFrame': 'At 24 hours', 'description': 'The skin condition grading scale assesses the condition of the skin on the abdomen and dorsum of the hands/feet based on drying, erythema, crusting, oozing, etc. on a continuous scale from 1 (normal) to 9 (vesicles or pustules)'}, {'measure': 'Skin Temperature at 30 Min After Intervention', 'timeFrame': 'at 30 min after intervention', 'description': 'Axillary skin temperature measured by a clinical thermometer kept in axilla for 3 minutes'}, {'measure': 'Number of Participants With Positive Skin Culture at Axilla', 'timeFrame': '24 hours after intervention', 'description': 'Occurrence of any bacterial flora irrespective of the colony count in the skin swabs from axilla at 24 hrs after intervention'}], 'secondaryOutcomes': [{'measure': 'Incidence of Clinical and Culture Positive Sepsis', 'timeFrame': 'First week of life', 'description': 'Infants with symptoms and/or signs suggestive of sepsis and a positive blood culture (with known pathogens and coagulase negative staphylococcus) were diagnosed to have culture positive sepsis; Those with negative cultures but with positive sepsis screen were classified as having clinical sepsis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chlorhexidine', 'preterm', 'newborn', 'skin condition', 'temperature', 'skin flora'], 'conditions': ['Neonatal Sepsis', 'Low Birth Weight']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine if single skin cleansing with 0.25% chlorhexidine affects skin condition, temperature, and bacterial colonization in stable preterm (28-36 weeks gestational age) low birth weight (1001-2000 g) infants admitted in a health facility.', 'detailedDescription': 'Infections are the leading cause of death in neonates admitted to hospital - studies from developing countries suggest that about 25-71% of deaths occurring in neonatal intensive care units are secondary to infections.Such high infection-related mortality mandates an urgent implementation of simple and effective measures to prevent the occurrence of infections in these units.\n\nThe majority of neonatal infections occur in the first two weeks of life, when the epidermal barrier is immature and functionally compromised. Topical application of antiseptics until the skin matures could theoretically prevent skin colonization and reduce the incidence of systemic infections in neonates. Chlorhexidine, a broad-spectrum antiseptic used frequently for umbilical cord care in neonates, is now being evaluated for topical application to the skin. Hospital-based studies, involving predominantly term infants, have shown reductions in skin flora8 and a reduction in the incidence of sepsis following topical chlorhexidine application. In a community-based study in Nepal, a single skin cleansing with 0.25% chlorhexidine resulted in reduction in mortality among low birth weight infants; though the mechanism of the impact could not be determined, it was presumably due to increased susceptibility to transcutaneous sepsis in the low birth weight group.\n\nSince the risk of infection in neonates is inversely related to their gestation, it is essential to evaluate the effect and the mechanism of such intervention in preterm neonates. These infants are, however, more prone to develop skin reactions following use of topical antiseptics. Preterm infants are also more prone to develop hypothermia following bathing/cleansing with antiseptic solution(s).\n\nSince few studies have evaluated the effects of topical application of chlorhexidine in preterm infants admitted in a health care facility, we conducted the present study to examine if single skin cleansing with 0.25% chlorhexidine immediately after birth affects skin condition, temperature, and colonization in hospitalized preterm low birth weight infants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Preterm infants of 28 to 36 weeks' gestation\n* Birth weights between 1001 and 2000 g\n\nExclusion Criteria:\n\n* Infants with one minute Apgar score \\< 4\n* Hemodynamic instability\n* Congenital malformations\n* Generalized skin disorder and\n* Infants who need respiratory support (continuous positive airway pressure and/or intermittent mandatory ventilation) in the first 2-3 hours of life"}, 'identificationModule': {'nctId': 'NCT00947518', 'briefTitle': 'Safety of Skin Cleansing With Chlorhexidine in Preterm Low Birth Weight Infants', 'organization': {'class': 'OTHER', 'fullName': 'All India Institute of Medical Sciences'}, 'officialTitle': 'Does Skin Cleansing With Chlorhexidine Affect Skin Condition, Temperature and Colonization in Hospitalized Preterm Low Birth Weight Infants?: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '10/2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine skin cleansing', 'description': 'Wiping the skin (except the face) once immediately after birth using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)', 'interventionNames': ['Drug: Chlorhexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline skin cleansing', 'description': 'Wiping the skin (except the face) once immediately after birth using baby wipes containing normal saline', 'interventionNames': ['Drug: Normal saline']}, {'type': 'NO_INTERVENTION', 'label': 'No skin cleansing', 'description': 'No skin application'}], 'interventions': [{'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'Baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)', 'armGroupLabels': ['Chlorhexidine skin cleansing']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Cleansing the skin (except the face)with baby wipes containing normal saline', 'armGroupLabels': ['Saline skin cleansing']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mari J Sankar, MD DM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi'}, {'name': 'Vinod K Paul, MD PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi'}, {'name': 'Ashok K Deorari, MD MNAMS', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Pediatrics, All India Institute of Medical Sciences, New Delhi'}, {'name': 'Gary L Darmstadt, MD MS', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'All India Institute of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'M Jeeva Sankar', 'oldOrganization': 'Department of Pediatrics, AIIMS, New Delhi'}}}}