Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-24 @ 5:29 AM
Study NCT ID:
NCT04095702
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2019-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weighted Pacifier Vs. Non-Weighted Pacifier
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2019-08-22', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety determined by a Neonatal Infant Pain Scale (NIPS) score', 'timeFrame': '48 hours', 'description': 'To determine if the weighted pacifier is safe in supporting non-nutritive suck. Neonates will be measured in facial expression, cry, breathing pattern, and state of arousal. Each category get a rating of 0 or 1, with 0 being negative and 1 being positive.'}, {'measure': 'efficiency determined by an Efficiency of Loss scale', 'timeFrame': '48 hours', 'description': "To determine if the weighted pacifier is efficient in supporting non-nutritive suck. The neonates will be observed for a period of 10 minutes each time the pacifier is introduced. The observer will count the amount of time the neonate's pacifier pop from his/her mouth."}], 'secondaryOutcomes': [{'measure': 'Stress/ Discomfort determined by a Likert Scale', 'timeFrame': '48 hours', 'description': 'To determine if a stabilized pacifier reduces infant stress/discomfort'}, {'measure': 'Caregiver stress determined by a Likert Scale', 'timeFrame': '48 hours', 'description': "To determine if a caregiver's stress level decreases when an infant is provided with a stabilizing/weighted pacifier versus a traditional pacifier. The scale will consist of questions asking about the caregiver's stress. The caregiver will answer the questions with a 1-5 rating, with 1 being strongly disagree and 5 being strongly agree."}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-nutritive Sucking']}, 'descriptionModule': {'briefSummary': 'This study will determine if it is beneficial to use a weighted pacifier in neonates.', 'detailedDescription': 'RCI-Pacifiers have been utilized for decades in the NICU to provide benifical Non-Nutritive Suck. They have been instrumental in transitioning premature infants from gavage to breast feeding Yiallouerou, S, et al, studied the effects of dummy/pacifier on autonomic activity during sleep and found pacifier use to be protective during sleep. Risks and Benefits of Pacifiers have cleary been identified Sexton, S and Natsale, R have identified that nonnutritive suck is a natural reflex for a fetus and newborn. Traditionally, the pacifier has been used as a method for fulfilling an infants innate desire to suckle. Study subjects will be introduced to either a standard/traditional pacifier (without stabilizing/weighted attachment) or a stabilizing/weighted pacifier. Standard/traditional pacifiers will be issued to patients that have been assigned an odd number study identifier and , stabilzing/weighted pacifiers will be issued to patients that have been assigned an even number study identifier. All eligible infants born at 30 weeks to 37.6 weeks who meet study criteria will be included. All staff/caregivers will be trained in proper placement of a stabilizing pacifier prior to use. Stabilizing pacifiers will not be placed on the infants chest. Traditional pacifiers will be used as standard of care at EH. The Neonatal Infant Pain Score (NIPS) scale and a caregiver survey will be used to determine efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'minimumAge': '30 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion\n\n* 30 week-37.6 gestational age\n* Patient is admitted to the NICU\n* The patient has the ability to suck as noted in the patient's infant assessment flow sheet prior to enrollment\n\nExclusion\n\n* Patient with an oral pharyngeal defect\n* Patient with an oral feeding tube\n* Patient with any medical reason that deems them unfit for the study as '''''''determined by the neonatologist\n* Patient with sustained apnea during sucking"}, 'identificationModule': {'nctId': 'NCT04095702', 'briefTitle': 'Weighted Pacifier Vs. Non-Weighted Pacifier', 'organization': {'class': 'OTHER', 'fullName': 'Englewood Hospital and Medical Center'}, 'officialTitle': 'A Pilot Study to Look at the Use of Stabilizing (Weighted) Pacifier vs. the Use of a Traditional Non-Stabilizing (Non-Weighted) Pacifier to Improve Infant Comfort, Caregiver Satisfaction, and Safety During Non-Nutritive Sucking', 'orgStudyIdInfo': {'id': 'E-19-782'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Weighted Pacifier', 'description': 'Patient will receive a weighted pacifier for 48 hours of their stay in the NICU.', 'interventionNames': ['Other: Weighted Pacifier']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non-Weighted Pacifier', 'description': 'Patient will receive a standard non-weighted pacifier for 48 hours of their stay in the NICU.', 'interventionNames': ['Other: Non-Weighted Pacifier']}], 'interventions': [{'name': 'Weighted Pacifier', 'type': 'OTHER', 'description': 'The weighted pacifier is a standard of care pacifier with a weighted, breathable star attachment to help keep the pacifier from popping out of the neonates mouth during non-nutritive suck.', 'armGroupLabels': ['Weighted Pacifier']}, {'name': 'Non-Weighted Pacifier', 'type': 'OTHER', 'description': 'The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.', 'armGroupLabels': ['Non-Weighted Pacifier']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07631', 'city': 'Englewood', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Englewood Health', 'geoPoint': {'lat': 40.89288, 'lon': -73.97264}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Englewood Hospital and Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}