Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-27 @ 11:56 PM
Study NCT ID:
NCT05530733
Status:
COMPLETED
Last Update Posted:
2024-10-16
First Post:
2022-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041361', 'term': 'Pacifiers'}, {'id': 'D008895', 'term': 'Milk, Human'}], 'ancestors': [{'id': 'D015370', 'term': 'Infant Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-13', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-09-06', 'lastUpdatePostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart rate change', 'timeFrame': '5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding', 'description': 'Heart rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.'}, {'measure': 'Respiratory rate change', 'timeFrame': '5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding', 'description': 'Respiratory rate will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.'}, {'measure': 'Saturation level change', 'timeFrame': '5 minutes before tube feeding, during tube feeding and 5 minutes after tube feeding', 'description': 'Saturation level will be measured 5 minutes before tube feeding, during tube feeding and 5 minutes after the end of tube feeding.'}, {'measure': 'Feeding duration', 'timeFrame': 'measured with a stopwatch for 7 months.', 'description': "Each baby's tube feeding duration will be measured."}, {'measure': 'Gastric residual volume', 'timeFrame': 'Gastric residue will be measured 2 hours after the end of infant feeding.', 'description': 'Gastric residue will be measured 2 hours after the end of infant feeding.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature', 'Pacifiers', 'Tube Feeding', 'Neonatal Nursing']}, 'descriptionModule': {'briefSummary': "The purpose of the study was to assess how preterm babies' vital signs, feeding time, and gastric residual volume were affected by using a pacifier only or a pacifier with breast milk during orogastric tube feeding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '34 Weeks', 'minimumAge': '29 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Feeding with the orogastric tube\n* Breastmilk along with formula (babies who receive more than 50% of their total feed in 24 hours from formula)\n* Gestation week between 29+0 weeks and 34+0 weeks\n* Weight of 1000 g or more\n\nExclusion Criteria:\n\n* Receiving mechanical ventilator support\n* Development of sepsis\n* Presence of neurological disease\n* Presence of chromosomal or congenital anomalies\n* Presence of intraventricular bleeding\n* Unstable physiological parameters\n* No breast milk'}, 'identificationModule': {'nctId': 'NCT05530733', 'briefTitle': 'Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Zonguldak Bulent Ecevit University'}, 'officialTitle': 'Clinical Effects of Pacifier Use in Preterm During Orogastric Tube Feeding: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BEU-YTASDELEN-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Pacifier only', 'description': 'Participants in the pacifier-only group will get a pacifier five minutes prior to tube feeding. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the volume of gastric residue will be controlled.', 'interventionNames': ['Procedure: Pacifier']}, {'type': 'OTHER', 'label': 'Pacifier with breast milk', 'description': 'Five minutes prior to tube feeding, participants in the pacifier with breast milk group will get their own breast milk dripping pacifier. During feedings, a pacifier will be employed. Five minutes following the end of tube feeding, the pacifier application will be discontinued. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled.', 'interventionNames': ['Procedure: Pacifier', 'Procedure: Breast milk']}, {'type': 'NO_INTERVENTION', 'label': 'standard care (no pacifier)', 'description': 'The premature babies in the standard care (no pacifier) will get standard care while being fed through an orogastric tube. The vital signs will be monitored prior to, during, and following feeding. Two hours after the feeding has finished, the amount of gastric residue will be controlled.'}], 'interventions': [{'name': 'Pacifier', 'type': 'PROCEDURE', 'description': 'Pacifiers produced for premature babies will be used in the study. Pacifiers will be made of silicone material suitable for premature baby health and will not contain any harmful substances. A separate pacifier will be used for each baby, and pacifiers will be sterilized before use.', 'armGroupLabels': ['Pacifier only', 'Pacifier with breast milk']}, {'name': 'Breast milk', 'type': 'PROCEDURE', 'description': 'For babies assigned to the pacifier with breast milk group, their own breast milk will be applied by dripping 1 ml into the pacifier.', 'armGroupLabels': ['Pacifier with breast milk']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zonguldak', 'state': 'Kozlu', 'country': 'Turkey (Türkiye)', 'facility': 'Yeliz Taşdelen', 'geoPoint': {'lat': 41.45139, 'lon': 31.79305}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zonguldak Bulent Ecevit University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Nurse, Research assistant', 'investigatorFullName': 'Yeliz Taşdelen', 'investigatorAffiliation': 'Zonguldak Bulent Ecevit University'}}}}