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Clinical Trials/NCT01666457
NCT01666457
Completed
N/A

The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU

Ann & Robert H Lurie Children's Hospital of Chicago1 site in 1 country156 target enrollmentSeptember 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Oral Feeding Outcomes
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Enrollment
156
Locations
1
Primary Endpoint
Oral Feeding Outcomes
Status
Completed
Last Updated
7 years ago

Overview

Brief 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?
Registry
clinicaltrials.gov
Start Date
September 2009
End Date
June 30, 2017
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan M Horner, MS, APN/CNS, RNC-NIC

Developmental Specialist

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

Inclusion Criteria

  • Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample

Exclusion Criteria

  • Infants with medical diagnoses known to impact sucking and swallowing
  • 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

Outcomes

Primary Outcomes

Oral Feeding Outcomes

Time Frame: Up to 5 months

Infant oral feeding outcomes per structured parent phone interview at home.

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.

Secondary Outcomes

  • Growth Outcomes(Up to 5 months)
  • Growth outcomes(Up to 3 months)

Study Sites (1)

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