Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-20 @ 2:49 PM
Study NCT ID:
NCT04118751
Status:
UNKNOWN
Last Update Posted:
2020-06-05
First Post:
2019-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-04', 'studyFirstSubmitDate': '2019-10-04', 'studyFirstSubmitQcDate': '2019-10-07', 'lastUpdatePostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bonding between primary caregiver and infant', 'timeFrame': 'From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery', 'description': 'Mean score of both parents of preterm babies hospitalized in NICU and parent of full-term babies on Postpartum Bonding Questionnaire (PBQ). Total score of the PBQ, a parent-rated screening instrument for disorders of the early parent-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).'}], 'secondaryOutcomes': [{'measure': 'Parental depression', 'timeFrame': 'From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery', 'description': "Mean score of parents of preterm infants hospitalized in NICU on Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item validated self-report instrument assessing mothers' postpartum depressive symptoms, excluding somatic symptoms of depression that are common in new mothers (such as loss of energy, feeling tired, changes in appetite and sexual drive). Sum scores can range from 0 to 30, with high scores indicating more depressive symptoms."}, {'measure': 'Parental anxiety', 'timeFrame': 'From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery', 'description': 'Mean score of both parents of preterm infants hospitalized in NICU on Generalized Anxiety Disorder Assessment (GAD-7). The GAD-7 is a self-report 7-item questionnaire serving as a screening tool and severity measure for generalized anxiety disorder. Sum scores can range from 0 to 21, with higher scores indicating higher anxiety.'}, {'measure': 'Parental stress', 'timeFrame': 'From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery', 'description': 'Mean score of both parents of preterm infants hospitalized in NICU on Parental Stress Scale (PSS). PSS is a self-report 18-item questionnaire that assesses stress associated with parenting. Sum scores can range from 18 to 90, with higher scores indicating higher stress.'}, {'measure': 'Bonding between mother and infant', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Mean score of both parents of preterm babies hospitalized in NICU and parent of full-term babies on Postpartum Bonding Questionnaire (PBQ). Total score of the PBQ, a parent-rated screening instrument for disorders of the early parent-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).'}]}, 'conditionsModule': {'keywords': ['Parental outcomes', 'Bonding', 'NICU'], 'conditions': ['Premature Birth']}, 'referencesModule': {'references': [{'pmid': '33897536', 'type': 'DERIVED', 'citation': 'Bieleninik L, Lutkiewicz K, Jurek P, Bidzan M. Paternal Postpartum Bonding and Its Predictors in the Early Postpartum Period: Cross-Sectional Study in a Polish Cohort. Front Psychol. 2021 Apr 9;12:628650. doi: 10.3389/fpsyg.2021.628650. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': "The main objective of this project is examining whether there is a relationship between preterm delivery and parental' problematic emotional bond in the early postpartum period.\n\nThe secondary outcomes are as follows:\n\n* To evaluate whether there are any differences and similarities between fathers' and mothers' level of parental bonding, stress, anxiety, and depression symptoms in case of premature birth.\n* To evaluate whether there is a relationship between preterm delivery and the persistence of maternal' problematic emotional bond three months after childbirth.\n* To indicate what kind of predictors might affect the parental' problematic bond in the early postpartum period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The investigators will approach parents of preterm babies (born before 37 weeks of pregnancy) and parents of babies born on time (over 37 weeks of pregnancy). Patients will be recruited for the study after delivery and will be enrolled after giving their written consent to participate in the study.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parents of children born below the 37th week of pregnancy (clinical group) or above the 37th week of pregnancy (control group) hospitalised in a neonatal setting during recruitment period\n* Which agreed participating to the study after having complete information about it and sign a consent.\n\nExclusion Criteria:\n\n* Parents may not participate in the study if one of them suffers from a serious mental illness.'}, 'identificationModule': {'nctId': 'NCT04118751', 'briefTitle': "Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond", 'organization': {'class': 'OTHER', 'fullName': 'University of Gdansk'}, 'officialTitle': 'Impact of Premature Childbirth on Parental Outcomes During Baby\'s NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort', 'orgStudyIdInfo': {'id': '9/2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'parents of preterm babies (born before 37 weeks of pregnancy'}, {'label': 'parents of full-term babies (over 37 weeks of pregnancy)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-210', 'city': 'Gdansk', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Łucja Bieleninik, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mariola Bidzan, Prof', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joanna Preis-Orlikowska, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Gdańsk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}], 'centralContacts': [{'name': 'Łucja Bieleninik, PhD', 'role': 'CONTACT', 'email': 'lucja.bieleninik@ug.edu.pl', 'phone': '0048 504 091 477'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Łucja Bieleninik', 'investigatorAffiliation': 'University of Gdansk'}}}}