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

Growth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666457
• Other study ID #: 2009-13949 Horner
• Status: Completed
• Start date: September 2009
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 30, 2017
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 5 Months

Eligibility

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

Related Conditions & MeSH terms

• Growth
• Length of NICU Stay
• Oral Feeding Outcomes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Ann & Robert H Lurie Childrens Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay	Length of stay in days in the NICU	Up to 3 months
Other	Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI	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.	Up to 2 years
Primary	Oral feeding outcomes	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.	Up to 3 months
Primary	Oral Feeding Outcomes	Infant oral feeding outcomes per structured parent phone interview at home.	Up to 5 months
Secondary	Growth outcomes	Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge	Up to 3 months
Secondary	Growth Outcomes	Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.	Up to 5 months