Clinical trial NCT01666457: Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Feeding Outcomes
Growth
Length of NICU Stay
Keywords: Supporting Oral Feeding in Fragile Infants (SOFFI)
Infant Oral Feeding
Infant Growth
Preterm infant oral feeding
Preterm infant growth
Neonatal Intensive Care Unit (NICU)
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 156
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Convenience sample of NICU infants discharged home prior to the implementation of the SOFFI will be compared to a convenience sample of NICU infants discharged home following the implementation of the SOFFI.

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?


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

Primary outcomes:
measure: Oral feeding outcomes
timeFrame: Up to 3 months
measure: Oral Feeding Outcomes
timeFrame: Up to 5 months
Secondary outcomes:
measure: Growth outcomes
timeFrame: Up to 3 months
measure: Growth Outcomes
timeFrame: Up to 5 months
Other outcomes:
measure: Length of Stay
timeFrame: Up to 3 months
measure: Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI
timeFrame: Up to 2 years
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Childrens Hospital of Chicago
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Susan M Horner, MS
role: PRINCIPAL_INVESTIGATOR
References: