Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
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|ClinicalTrials.gov Identifier: NCT01666457|
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : August 20, 2012
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.
The specific research questions considered in this study are:
- 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?
- 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?
- What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
- 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?
|Condition or disease||Intervention/treatment|
|Oral Feeding Outcomes Growth Length of NICU Stay||Other: SOFFI|
|Study Type :||Observational|
|Actual Enrollment :||156 participants|
|Official Title:||The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU|
|Study Start Date :||September 2009|
|Primary Completion Date :||September 2011|
Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.
Post SOFFI infants
Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and
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 Name: Supporting Oral Feedings in Fragile Infants
- Oral feeding outcomes [ Time Frame: Up to 3 months ]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.
- Oral Feeding Outcomes [ Time Frame: Up to 5 months ]Infant oral feeding outcomes per structured parent phone interview at home.
- Growth outcomes [ Time Frame: Up to 3 months ]Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge
- Growth Outcomes [ Time Frame: Up to 5 months ]Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.
- Length of Stay [ Time Frame: Up to 3 months ]Length of stay in days in the NICU
- Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI [ Time Frame: Up to 2 years ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666457
|United States, Illinois|
|Ann & Robert H Lurie Childrens Hospital of Chicago|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Susan M Horner, MS||Ann & Robert H Lurie Children's Hospital of Chicago|