Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
NCT ID: NCT01666457
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
156 participants
OBSERVATIONAL
2009-09-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The specific research questions considered in this study are:
1. 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?
2. 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?
3. What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
4. 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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of a Standard Preterm Infant Formula Fed to Preterm Infants in the Hospital
NCT01766011
Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants
NCT01989871
New Infant Formula Supports Adequate Growth in Healthy Infants
NCT03614468
Post-Discharge Growth and Development of Infants Who Received Targeted Fortification in the NICU
NCT04190875
Prolonged Minimal Enteral Nutrition Versus Slowly Advancing Enteral Nutrition in Very Low Birth Weight Infants:
NCT02913677
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pre-SOFFI infants
Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.
No interventions assigned to this group
Post SOFFI infants
Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and
SOFFI
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SOFFI
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Infants unable to manage their oral secretions
* Infants who remain hospitalized beyond 3 months adjusted age
* Infants who expire or are transferred to another inpatient unit or hospital/facility prior to discharge from the NICU
3 Months
5 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Susan M Horner, MS, APN/CNS, RNC-NIC
Developmental Specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Susan M Horner, MS
Role: PRINCIPAL_INVESTIGATOR
Ann & Robert H Lurie Children's Hospital of Chicago
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ann & Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-13949 Horner
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.