Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)

Completed

• Conditions: Oral Feeding Outcomes; Length of NICU Stay; Growth
• Interventions: Other: SOFFI

• Registration Number: NCT01666457
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2011-09
• Study First Submitted: 2012-08-13
• Study First Submitted QC: 2012-08-14
• Study First Posted: 2012-08-16
• Study Completion: 2017-06-30
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-16
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post SOFFI infants	SOFFI	Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and

Primary Outcome Measures

Name	Time	Method
Oral Feeding Outcomes	Up to 5 months	Infant oral feeding outcomes per structured parent phone interview at home.
Oral feeding outcomes	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 Outcome Measures

Name	Time	Method
Growth Outcomes	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.
Growth outcomes	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

Trial Locations

Locations (1)

Ann & Robert H Lurie Childrens Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States