Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2026-01-08 @ 5:16 PM
Study NCT ID:
NCT03070158
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2017-02-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Affective Bonding in Mothers and Their Premature Newborn
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-06', 'studyFirstSubmitDate': '2017-02-28', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Affective bonding score', 'timeFrame': '1-6 weeks', 'description': 'Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)'}], 'secondaryOutcomes': [{'measure': 'Coping adaptation score', 'timeFrame': '1-6 weeks', 'description': 'Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Premature Infant', 'Mother-Infant Interaction', 'Acoustic stimulation/methods', 'Touch', 'Visual Stimulation', 'Vestibule, Labyrinth/physiology'], 'conditions': ['Premature Infant']}, 'referencesModule': {'references': [{'pmid': '22161578', 'type': 'BACKGROUND', 'citation': 'Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.'}, {'pmid': '22703676', 'type': 'BACKGROUND', 'citation': 'Kelly MM. Comparison of functional status of 8- to 12-year-old children born prematurely: an integrative review of literature. J Pediatr Nurs. 2012 Aug;27(4):299-309. doi: 10.1016/j.pedn.2011.03.010. Epub 2011 May 11.'}, {'pmid': '21045616', 'type': 'BACKGROUND', 'citation': 'Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.'}, {'pmid': '21350371', 'type': 'BACKGROUND', 'citation': 'Howland LC, Pickler RH, McCain NL, Glaser D, Lewis M. Exploring biobehavioral outcomes in mothers of preterm infants. MCN Am J Matern Child Nurs. 2011 Mar-Apr;36(2):91-7. doi: 10.1097/NMC.0b013e318205587e.'}, {'pmid': '20951514', 'type': 'BACKGROUND', 'citation': 'Forcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.'}]}, 'descriptionModule': {'briefSummary': 'This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.', 'detailedDescription': 'The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '36 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPremature Infant:\n\n* Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.\n* Apgar to the minute and five minutes greater to 7/10\n\nMother:\n\n* Mother with nursing diagnosis: Risk of impaired attachment.\n* Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth\n* Mother living in the metropolitan perimeter of the city of Bucaramanga\n\nExclusion Criteria:\n\nNewborn:\n\n* Infants that underwent surgery\n* Infants with neurological injury.\n* Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.\n\nMother:\n\n* Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.\n* Mother consuming psychoactive substances.\n* With mental alterations, verified in the medical history.'}, 'identificationModule': {'nctId': 'NCT03070158', 'briefTitle': 'Affective Bonding in Mothers and Their Premature Newborn', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Industrial de Santander'}, 'officialTitle': 'Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond', 'orgStudyIdInfo': {'id': '1900'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Attachment Promotion Intervention', 'description': 'Mothers will receive the intervention which includes an education session about newborn care, training in multisensory stimulation with the intervention ATVV and two domiciliary visits to follow up the mother and her premature infant.', 'interventionNames': ['Behavioral: Attachment Promotion']}, {'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Mothers will continue to receive usual which consist in education session about newborn care in home.'}], 'interventions': [{'name': 'Attachment Promotion', 'type': 'BEHAVIORAL', 'description': 'Attachment Promotion consists of:\n\n1. Education session about newborn and mother care.\n2. Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)\n3. Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.\n4. Daily Phone follows up.', 'armGroupLabels': ['Attachment Promotion Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '680002', 'city': 'Bucaramanga', 'state': 'Santander Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Beatriz Villamizar- Carvajal, PhD', 'role': 'CONTACT', 'email': 'beatriz@uis.edu.co', 'phone': '576345745'}, {'name': 'Beatriz Villamizar- Carvajal, RN PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Carolina Vargas- Porras, RN MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mayut Delgado- Galeano, RN MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Nursing School, Universidad Industrial de Santander', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '680003', 'city': 'Bucaramanga', 'state': 'Santander Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'CRISTIAN ORDOÑEZ, Dr.', 'role': 'CONTACT', 'email': 'asistente.medica@clinicasanluis.com.co', 'phone': '5776430026', 'phoneExt': '495'}], 'facility': 'Clinica Materno Infantil San Luis', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}, {'zip': '680003', 'city': 'Bucaramanga', 'state': 'Santander Department', 'status': 'RECRUITING', 'country': 'Colombia', 'contacts': [{'name': 'Helda Amaya, RN.Director', 'role': 'CONTACT', 'email': 'heldow2003@yahoo.com', 'phone': '577 6450102'}], 'facility': 'Hospital Universitario de Santander', 'geoPoint': {'lat': 7.125, 'lon': -73.11895}}], 'centralContacts': [{'name': 'Beatriz Villamizar- carvajal, PhD', 'role': 'CONTACT', 'email': 'beatriz@uis.edu.co', 'phone': '5776345745'}, {'name': 'Mayut Delgado-Galeano, Msc', 'role': 'CONTACT', 'email': 'mayutdelgado@gmail.com', 'phone': '573204790489'}], 'overallOfficials': [{'name': 'Beatriz Villamizar- Carvajal, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad Industrial de Santander'}, {'name': 'Carolina Vargas- Porras, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Industrial de Santander'}, {'name': 'Mayut Delgado-Galeano, Msc', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad Industrial de Santander'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Industrial de Santander', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Beatriz Villamizar Carvajal', 'investigatorAffiliation': 'Universidad Industrial de Santander'}}}}