Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-02 @ 1:52 PM
Study NCT ID:
NCT05362604
Status:
COMPLETED
Last Update Posted:
2022-05-05
First Post:
2022-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-30', 'studyFirstSubmitDate': '2022-02-08', 'studyFirstSubmitQcDate': '2022-04-30', 'lastUpdatePostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gestational age of delivery', 'timeFrame': '1 year', 'description': 'weeks'}, {'measure': 'mode of delivery', 'timeFrame': '1 year', 'description': 'Vaginal, Operative vaginal, Elective cesarean section, Cesarean section for fetal indication'}], 'secondaryOutcomes': [{'measure': 'neonatal morbidity', 'timeFrame': '1 year', 'description': 'Age at surgery, Cutaneous stoma, Anastomotic leakage, Mechanical ventilation, Phototherapy, Infection'}, {'measure': 'length of hospital stay', 'timeFrame': '1 year', 'description': 'Length of neonatal intensive care unit stay, Length of neonatal reanimation stay (days)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Antenatal Management of the Fetal Gastrointestinal Atresia']}, 'descriptionModule': {'briefSummary': 'Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.\n\nMethods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive pregnancies, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.', 'detailedDescription': 'Aim- to investigate how prenatal diagnosis of fetal esophageal or intestinal atresia impacts obstetric and neonatal outcomes.\n\nMethods- This was a retrospective cohort study at a single center. The study population comprised 51 consecutive participants, including 29 mothers (57%) and their fetuses affected by prenatally diagnosed fetal esophageal or intestinal atresia, and 22 mothers (43%) and their babies with postnatally diagnosed fetal esophageal or intestinal atresia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '51 mother-baby pairs', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all pregnancies affected by fetal esophageal, duodenal or intestinal atresia referred to our prenatal diagnosis unit\n* all newborns managed for such atresia in our unit of pediatric surgery\n\nExclusion Criteria:\n\n* termination of pregnancy,\n* stillbirth,\n* the false positive cases'}, 'identificationModule': {'nctId': 'NCT05362604', 'acronym': 'DANATRESIA', 'briefTitle': 'Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Top Benefits of the Prenatal Diagnosis of the Fetal Esophageal or Intestinal Atresia', 'orgStudyIdInfo': {'id': 'DANATRESIA'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'prenatal', 'description': "patients affected by confirmed fetal esophageal, duodenal or intestinal atresia and followed in our high-risk pregnancy unit, and scheduled for delivery between 38 and 39 weeks in our tertiary center, regardless of the patient's place of residence", 'interventionNames': ['Procedure: scheduled delivery at a tertiary center']}, {'label': 'postnatal', 'description': 'patients with unsuspected fetal atresia who delivered in their local hospitals: their newborns were transferred to our tertiary hospital within 24 hours and the mother had the option to be also transferred in order to follow her baby.'}], 'interventions': [{'name': 'scheduled delivery at a tertiary center', 'type': 'PROCEDURE', 'description': 'Neonatal units in French hospitals are classified in three levels. The intention is for infants requiring high level care to receive it in a tertiary neonatal unit within the same network when appropriate. In case of known fetal gastro-intestinal artesia, the prenatal care includes obstetric consultation and level 3 ultrasound scheduled every four weeks at our unit until the end of the pregnancy, antenatal consultations with a specialized multidisciplinary team, and an antenatal visit of the birth center to reduce the parental anxiety.', 'armGroupLabels': ['prenatal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}