Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-22 @ 6:57 AM
Study NCT ID:
NCT01666457
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2012-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-16', 'studyFirstSubmitDate': '2012-08-13', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Length of Stay', 'timeFrame': 'Up to 3 months', 'description': 'Length of stay in days in the NICU'}, {'measure': "Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI", 'timeFrame': 'Up to 2 years', 'description': 'Measured by staff surveys done prior to and at least 3 months following SOFFI training with NICU staff. Two surveys include one for Registered Nurses (RNs)and second survey for MD/Advanced Practice Nursing (APN) staff.'}], 'primaryOutcomes': [{'measure': 'Oral feeding outcomes', 'timeFrame': 'Up to 3 months', 'description': 'Defined as percentage of ordered full feeding volume as ordered by NICU staff taken orally at NICU discharge and, if applicable, the number of days to take 100% of ordered feeding volume orally.'}, {'measure': 'Oral Feeding Outcomes', 'timeFrame': 'Up to 5 months', 'description': 'Infant oral feeding outcomes per structured parent phone interview at home.'}], 'secondaryOutcomes': [{'measure': 'Growth outcomes', 'timeFrame': 'Up to 3 months', 'description': "Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge"}, {'measure': 'Growth Outcomes', 'timeFrame': 'Up to 5 months', 'description': 'Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Supporting Oral Feeding in Fragile Infants (SOFFI)', 'Infant Oral Feeding', 'Infant Growth', 'Preterm infant oral feeding', 'Preterm infant growth', 'Neonatal Intensive Care Unit (NICU)'], 'conditions': ['Oral Feeding Outcomes', 'Growth', 'Length of NICU Stay']}, 'descriptionModule': {'briefSummary': "The specific aim of this pre-post trial is to compare data regarding oral feeding, length of stay, and growth outcomes of 100 NICU infants to these same outcomes following the implementation of a developmentally supportive, infant driven feeding program with the NICU staff, specifically the Supporting Oral Feeding in Fragile Infants (SOFFI) infant feeding program on a second sample of 100 NICU infants at Children's Memorial Hospital.\n\nThe specific research questions considered in this study are:\n\n1. What is the impact of implementing the SOFFI on the oral feeding outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?\n2. What is the impact of implementing the SOFFI on the growth outcomes of medically fragile infants in the NICU at discharge and at 3 months post-term?\n3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?\n4. What is the impact of implementing the SOFFI on the clarity and consistency of NICU staff evaluations and communications related to managing oral feedings with medically fragile infants?"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '5 Months', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Convenience sample of NICU infants discharged home prior to the implementation of the SOFFI will be compared to a convenience sample of NICU infants discharged home following the implementation of the SOFFI.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample\n\nExclusion Criteria:\n\n* Infants with medical diagnoses known to impact sucking and swallowing\n* Infants unable to manage their oral secretions\n* Infants who remain hospitalized beyond 3 months adjusted age\n\n * Infants who expire or are transferred to another inpatient unit or hospital/facility prior to discharge from the NICU'}, 'identificationModule': {'nctId': 'NCT01666457', 'briefTitle': 'Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU', 'orgStudyIdInfo': {'id': '2009-13949 Horner'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pre-SOFFI infants', 'description': 'Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.'}, {'label': 'Post SOFFI infants', 'description': 'Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and', 'interventionNames': ['Other: SOFFI']}], 'interventions': [{'name': 'SOFFI', 'type': 'OTHER', 'otherNames': ['Supporting Oral Feedings in Fragile Infants'], 'description': 'NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.', 'armGroupLabels': ['Post SOFFI infants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Ann & Robert H Lurie Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Susan M Horner, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Ann & Robert H Lurie Children's Hospital of Chicago", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Developmental Specialist', 'investigatorFullName': 'Susan M Horner, MS, APN/CNS, RNC-NIC', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}