Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT01217658
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2010-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Measuring and Reducing Excessive Infant Crying
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003085', 'term': 'Colic'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D038642', 'term': 'Shaken Baby Syndrome'}], 'ancestors': [{'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-04', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean night-time crying', 'timeFrame': '2 weeks after enrollment. Appproximately 6-8 weeks of life.', 'description': 'Objectively recording night-time duration of excessive crying'}, {'measure': 'Mean sleep duration', 'timeFrame': '2 weeks after enrollment. Appproximately 6-8 weeks of life.', 'description': 'objectively measuring infant sleep duration'}], 'secondaryOutcomes': [{'measure': 'Maternal Depression, Anxiety and Somatization', 'timeFrame': 'At study entry and conculsion (4 week interval); 2 weeks after enrollment. Appproximately 6-8 weeks of life.', 'description': 'Using the BSI-18 at study enrollment and conclusion.'}, {'measure': 'Salivary Biomarkers', 'timeFrame': 'At Study Entry and at 2 weeks after enrollment', 'description': 'We are collecting maternal salivary cortisol and amylase at study entry and at study conclusion (within 2 weeks after enrollment)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized Trial', 'Infant Colic', 'Abusive Head Trauma', 'Shaken Baby Syndrome'], 'conditions': ['Infant Colic', 'Postpartum Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.healthychildren.org/english/ages-stages/baby/crying-colic/Pages/default.aspx', 'label': 'American Academy of Pediatrics Infant Colic Website'}]}, 'descriptionModule': {'briefSummary': 'Excessive infant crying (EIC) is likely to increase the risk of child abuse. The investigators propose a randomized trial using an intervention based on recommendations of Karp. The investigators will systematically identify 170 term infants with EIC and conduct assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces mean infant hours of night-time crying, increases maternal soothing behaviors and improves parental anxiety and depression.', 'detailedDescription': 'Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment parental soothing skills and reduces infant crying at night (primary outcome) and parental sleep loss, distress, \\& depression assessed in the home by a masked nurse at 8 wks.\n\nMethods: Term singleton infants with EIC (\\> 3 hrs/24h) recruited through a program offered to parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth. Consenting families (n=178) will be randomized to standard colic counseling (American Academy of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets). At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18), place dosimeters in rooms where the infant sleeps and spends most time, and apply the actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at a usual feeding time (when EIC is likely), record infant \\& maternal behaviors during crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992), and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05; beta = 0.20; effect size =0.5 SD, power = .90).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Weeks', 'minimumAge': '3 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* term, singleton neonates\n* otherwise healthy\n* parent must have at least a 6th grade understanding of English or Spanish\n* infant must have colic (greater than 3 hours of crying per day)\n* OR the infant's crying causes excessive stress on the either parent\n\nExclusion Criteria:\n\n* cannot have a condition which would reasonably impact alertness or behavior"}, 'identificationModule': {'nctId': 'NCT01217658', 'acronym': 'UTHealth THB', 'briefTitle': 'Measuring and Reducing Excessive Infant Crying', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Measuring and Reducing Excessive Infant Crying: A Randomized Trial', 'orgStudyIdInfo': {'id': 'HSC-MS-10-0392'}, 'secondaryIdInfos': [{'id': 'K23HD065872', 'link': 'https://reporter.nih.gov/quickSearch/K23HD065872', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The Happiest Baby on The Block', 'description': 'Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".', 'interventionNames': ['Behavioral: The Happiest Baby on The Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'AAP Education', 'description': 'Those receiving the control group allocation will be counseled in the American Academy of Pediatrics guidelines regarding Infant Colic (AAP Infant Colic counseling).', 'interventionNames': ['Behavioral: AAP Infant Colic counseling']}], 'interventions': [{'name': 'The Happiest Baby on The Block', 'type': 'BEHAVIORAL', 'description': 'Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".', 'armGroupLabels': ['The Happiest Baby on The Block']}, {'name': 'AAP Infant Colic counseling', 'type': 'BEHAVIORAL', 'description': 'Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.', 'armGroupLabels': ['AAP Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor - Pediatrics', 'investigatorFullName': 'Christopher Greeley', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}