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NCT01666457 · ClinicalTrials.gov registry record
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
A clinical trial, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Completed
- Registry status
- 156
- Enrollment target
NCT01666457: Completed study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
NCT01666457 is a clinical trial that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 156 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01666457 has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- COMPLETED
- Registry status
- 156 participants
- Enrollment target
Study Summary
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: 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?
Primary Outcome
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.
Interventions
- OTHER SOFFI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2009-09 |
| Est. Completion | 2017-06-30 |
What the finished NCT01666457 record still lists
NCT01666457 is an observational study that tracks outcomes without assigning an intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which SOFFI is the first listed.
NCT01666457 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01666457 about?
NCT01666457 is a clinical study titled "Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)". 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 Supporti...
What is the current status of trial NCT01666457?
This trial is currently completed. The enrollment target is 156 participants. The study started on 2009-09. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT01666457?
The interventions under investigation include: SOFFI (OTHER).
Who is sponsoring clinical trial NCT01666457?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
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