Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-01-27 @ 1:34 AM
Study NCT ID:
NCT02415361
Status:
COMPLETED
Last Update Posted:
2021-09-23
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow Ups of Parents With Infants With Cleft Lip and Palate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D002972', 'term': 'Cleft Palate'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-22', 'studyFirstSubmitDate': '2015-02-27', 'studyFirstSubmitQcDate': '2015-04-08', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)', 'timeFrame': '1 month post partum', 'description': 'Both groups'}, {'measure': 'Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)', 'timeFrame': '1 month post partum', 'description': 'Both Groups'}, {'measure': 'Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form', 'timeFrame': '1 month post partum', 'description': 'Both groups'}, {'measure': 'Infant growth as measured by "Demographic data Questionnaire" and "Child health card"', 'timeFrame': '1 month post partum', 'description': 'Both groups'}, {'measure': 'Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)', 'timeFrame': '1 month post partum', 'description': 'Both groups'}, {'measure': 'Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)', 'timeFrame': '6 months post partum', 'description': 'Both groups'}, {'measure': 'Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)', 'timeFrame': '6 months post partum', 'description': 'Both groups'}, {'measure': 'Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)', 'timeFrame': '13 months post partum', 'description': 'Both groups'}, {'measure': 'Infant growth as measured by "Child health card"', 'timeFrame': '13 months post partum', 'description': 'Both groups'}, {'measure': 'Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)', 'timeFrame': '13 months post partum', 'description': 'Both groups'}, {'measure': 'Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)', 'timeFrame': '6 months post partum', 'description': 'Both groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parents', 'Follow-Up Studies'], 'conditions': ['Cleft Lip', 'Cleft Palate']}, 'descriptionModule': {'briefSummary': "In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate\n* Birthplace in south-east region of Norway\n* Scandinavian speaking parents\n\nExclusion Criteria:\n\n* Parents of infants with CLP who are referred to the hospital after the first measure point\n* Birthplace outside south-east region of Norway\n* Non-scandinavian speaking parents'}, 'identificationModule': {'nctId': 'NCT02415361', 'briefTitle': 'Follow Ups of Parents With Infants With Cleft Lip and Palate', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Follow Ups of Parents With Infants With Cleft Lip and Palate', 'orgStudyIdInfo': {'id': '2014/17828'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Arm A', 'description': 'Standard care consists of:\n\n* a phone call from a CLP-nurse after the referral from the local birth hospital has been received\n* telephone service at parents request and at the staffs availability\n* invitation to a one-day-information course before surgery'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B', 'description': 'Systematic follow up by a special trained nurse consists of:\n\n* telephone contact with the parents shortly after birth\n* visit at the maternity ward within 36 hours after the referral has been received\n* telephone follow ups at specific times and at parents request\n* guidance and support in feeding and treatment\n* written information\n* cooperation with the staff at the maternity unit and the health centre\n* follow up in accordance with a check-list and log\n* invitation to a one-day-information course before surgery', 'interventionNames': ['Other: Cleft lip and palate']}], 'interventions': [{'name': 'Cleft lip and palate', 'type': 'OTHER', 'description': 'Comparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed.', 'armGroupLabels': ['Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo university hospital; Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Kim A Tønseth, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oslo University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Plastic and Reconstructive Surgery', 'investigatorFullName': 'Kim Alexander Tønseth', 'investigatorAffiliation': 'Oslo University Hospital'}}}}