Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT07101757
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neonatal Neurodevelopmental Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-07-18', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Intervention Implementation', 'timeFrame': '12 months', 'description': 'Assessed by the proportion of eligible participants who enroll and complete the intervention protocol.\n\nUnit of Measure: Percentage of participants completing the intervention.'}, {'measure': 'Acceptability of Intervention', 'timeFrame': '12 months', 'description': 'Measured using the Acceptability of Intervention Measure (AIM), a validated 4-item Likert scale assessing participant perceptions of the intervention.\n\nUnit of Measure: Mean AIM score (range: 1-5).'}, {'measure': 'Caregiver Mental Health Outcomes', 'timeFrame': '12 months', 'description': 'Evaluated using the Patient Health Questionnaire-9 (PHQ-9) for depression and the Generalized Anxiety Disorder-7 (GAD-7) scale for anxiety.\n\nUnit of Measure: Mean scores on PHQ-9 and GAD-7.'}, {'measure': 'Caregiver-Infant Bonding and Nurture', 'timeFrame': '12 months', 'description': 'Assessed using the Postpartum Bonding Questionnaire (PBQ) to evaluate caregiver-infant bonding.\n\nUnit of Measure: Mean PBQ score.'}, {'measure': 'Addressing Non-Medical Drivers of Health', 'timeFrame': '12 months', 'description': 'Measured by the number of referrals made to food, housing, or mental health resources and the proportion of participants who accessed at least one referred service.\n\nUnit of Measure: Count of referrals and percentage of participants accessing services.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Food Insecurity', 'Depression', 'Anxiety', 'Stress']}, 'descriptionModule': {'briefSummary': 'The main goal of this research is to help mothers with depression and anxiety to cope and bond with their baby.\n\nThe next goal is to provide resources to help with household needs like food, rent, or utility assistance, health insurance. Our theory is that helping with food insecurity, household needs, and emotional health will help children and families.', 'detailedDescription': 'The purpose of this study is to support families of children who are hospitalized. Participants will be asked to complete a survey regarding resources that may enhance caregiver wellbeing. These resources are intended to also support the health and developmental potential of the hospitalized child.\n\nThere is a small risk of loss of confidentiality associated with participation in the research; however, the investigators have implemented multiple safeguards to protect participant information. There is no guarantee of direct benefit from participation. If a need for resources is identified, participants may be referred to hospital-based food resources or a local food bank, which could be beneficial.\n\nAdditionally, many mothers of hospitalized children experience symptoms of depression, anxiety, and stress. A program is available within the hospital that includes access to a specialist and supportive resources for those experiencing such feelings.\n\nThe findings from this study may inform future efforts to assist caregivers more effectively. Participation in this research is voluntary, and individuals may instead request a social work consultation to determine eligibility for available resources without enrolling in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "The study will include adult caregivers (18 years or older) who speak English or Spanish and have infants aged 0-6 months hospitalized at Texas Children's Hospital. Caregivers must be willing to participate in study activities. Those without primary custody, living outside Texas, or previously enrolled in the study will not be eligible", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Caregivers of young infants (0-6 months of age) hospitalized at Texas Children's Hospital intensive care or acute care units.\n* English or Spanish speaking caregiver.\n* Age of caregiver ≥ 18 years old.\n* Caregiver willing to complete study procedures.\n\nExclusion Criteria:\n\n* Caregivers who do not have primary custody.\n* Caregivers who live outside of Texas (due to lack of Houston Food Bank resources outside of Texas).\n* Children in CPS custody.\n* Caregiver is not the primary caregiver.\n* Previous enrollment in this study.\n* Neonates who are non-viable"}, 'identificationModule': {'nctId': 'NCT07101757', 'briefTitle': 'Neonatal Neurodevelopmental Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Baylor College of Medicine'}, 'officialTitle': 'Neonatal Neurodevelopmental Outcomes: Addressing Family Needs and Strengthening the Caregiver-Baby Bond', 'orgStudyIdInfo': {'id': 'H-57296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Positive Screens', 'description': '* Enrollment survey\n* Referral to behavior health clinician (BHC)\n* Referral to emergency psychiatric services\n* Referral the Houston Food Bank (HFB)\n* Follow-up surveys'}, {'label': 'Negative Screens', 'description': '-Enrollment survey'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Lopez, MD, MPH', 'role': 'CONTACT', 'email': 'malopez@bcm.edu', 'phone': '832-824-6044'}], 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Michelle Lopez, MD, MPH', 'role': 'CONTACT', 'email': 'malopez@texaschildrens.org', 'phone': '832-824-6044'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD data will not be shared with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Episcopal Health Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Michelle Lopez', 'investigatorAffiliation': 'Baylor College of Medicine'}}}}