Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-29 @ 2:21 AM
Study NCT ID:
NCT04783220
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2021-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2021-01-15', 'studyFirstSubmitQcDate': '2021-03-03', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Child developmental outcome', 'timeFrame': '9 months', 'description': 'The developmental outcome of preterm children will be assessed using the Ages and Stages Questionnaire at 9 months of corrected age.\n\nThe ASQ-3 covers 5 area of child development : Gross Motor, Fine Motor, Problem Solving, Personal-Social, Communication.\n\nScores for each area should range between minimum 0 and maximum 60. Higher scores indicate that the child is developing properly.'}], 'secondaryOutcomes': [{'measure': 'Physiological state- Respiratory rate', 'timeFrame': '1 year', 'description': 'Physiological parameters including respiratory rate will be retrieved from the bedside monitors.'}, {'measure': 'Physiological state - Oxygen saturation', 'timeFrame': '1 year', 'description': 'Physiological parameters including oxygen saturation will be retrieved from the bedside monitors.'}, {'measure': 'Neurobehavioral state', 'timeFrame': '1 year', 'description': 'Behavioral state will be assessed by a cerified trained developmental specialist using a 7-point score that include: (i) Quiet/deep sleep, (ii) Active sleep, (iii) Awake State, (iv) drowsy, (v) quiet alert, (vi) active alert, (vii) crying'}, {'measure': 'Parental Knowledge assessment', 'timeFrame': 'Before hospital discharge', 'description': 'Parental knowledge assessment test will be administered before and after the education sessions using 10 true/false questions regarding topics addressed in the sessions.'}, {'measure': 'Parental stress', 'timeFrame': '1 year', 'description': 'The Arabic parenting stress index short form questionnaire will be used. The PSI-SF is a self-administered questionnaire and consists of 36 items divided into three subscales of 12 items each: parental distress, parent-child dysfunctional interaction and difficult child.\n\nFor each subscales scores ranges should be between 12 and 60. For the total stress score , the minimum score is 36 and the maximum is 180. Higher scores mean more depressive symptoms.'}, {'measure': 'Behavioral parenting activities', 'timeFrame': '1 year', 'description': 'A questionnaire derived from the UNICEF MICS 6 questionnaire will be used. MICS or "MULTIPLE INDICATOR CLUSTER SURVEY" is a tool used to assess the activities of parents with their infants.'}, {'measure': 'Parents perceptions', 'timeFrame': '1 year', 'description': "The Perceived Maternal Parenting Self-Efficacy questionnaire is a standardized valid and reliable instrument to assess parent's perceptions of their ability to care for their infants.\n\nPMP-SE is composed of 20 items divided into four subscales: care taking procedures, evoking behaviours, reading behaviours or signalling, and situational beliefs.\n\nThose items are formulated as statements using a five-point Likert scale. Scoring ranges from 20 to 80 where a higher score indicates a higher self-efficacy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preterm infant', 'Parental stress', 'Early child development', 'Parenting in the neonatal intensive care'], 'conditions': ['Behavioral Assessment of Children', 'Early Intervention']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://mics.unicef.org/tools', 'label': 'MICS6 TOOLS'}, {'url': 'http://healthit.ahrq.gov/ahrq-funded-projects/nicu-2-home-using-health-it-support-parents-nicu-graduates-transitioning-home', 'label': 'Agency for Healthcare Reserach and Quality (2018). NICU-2-HOME: Using Health IT to Support Parents of NICU Graduates Transitioning to Home (Illinois) \\| AHRQ National Resource Center; Health Information Technology: Best Practices Transforming Quality, S'}]}, 'descriptionModule': {'briefSummary': "Preterm infants are at high risk of developmental delay or disabilities and they do benefit from early intervention programs. Many programs aiming at improving preterm infants' developmental outcome have been proposed with mixed results. In low to middle-income countries, clinically relevant and effective low cost interventions empowering parents have yet to be established.", 'detailedDescription': "Education and intervention programs targeting parents of premature infants are lacking in low to middle income countries (LMIC) and in Arabic countries in particular. The main concept of this proposal is to develop a program in Arabic for parents of premature infants with the aim to increase their knowledge about short and long term problems of prematurity, increase their involvement in the care during their stay in the neonatal intensive care unit (NICU) and promote responsive and sensitive parenting in the NICU and after discharge. This is to empower parents and have them become active contributors to enhancing their infant's development through play activities and tracking of developmental milestones."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '21 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couplets of parents and their preterm infants admitted to the NICU, who are \\<35 weeks gestation at birth and who are deemed medically stable by their treating neonatologist.\n\nExclusion Criteria:\n\n* Infants with significant neurologic disorder precluding meaningful interaction with the parents as determined by the neurologist\n* Infants with major congenital anomalies precluding meaningful interaction with the parents as determined by the neurologist\n* Infants with systemic medical and/ or surgical conditions precluding interaction with the parents, other than preterm-related intraventricular hemorrhage (IVH) and periventricular leukomalacia (PVL).\n* Parental refusal to participate\n* Absence of clearance from the neonatologist\n* Infants planned to be transferred to another facility for their NICU care.'}, 'identificationModule': {'nctId': 'NCT04783220', 'acronym': 'PREPARE', 'briefTitle': "PaREnting ProgrAm to Enhance PREterm Infants' Health and Development (PREPARE Trial)", 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': "Comprehensive PaREnting ProgrAm to Enhance PREterm Infants' Health and Development: A Randomized Controlled Trial (PREPARE Trial)", 'orgStudyIdInfo': {'id': 'SBS-2020-0365'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'The parents of babies in this group will receive an educational and intervention program', 'interventionNames': ['Behavioral: Comprehensive structured parent intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The parents of babies in this group will receive the standard parent education and follow-up.'}], 'interventions': [{'name': 'Comprehensive structured parent intervention', 'type': 'BEHAVIORAL', 'description': "1. Educational sessions and coaching on infants' behavior cues\n2. Skills on motor stimulation\n3. Written instructions for play and stimulation activities at discharge\n4. Multidisciplinary follow-up\n5. Developmental tracking and advice via a mobile app", 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1107 2020', 'city': 'Beirut', 'state': 'Hamra', 'country': 'Lebanon', 'facility': 'American University of Beirut', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Lama Charafeddine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American University of Beirut Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}