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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01666457
Enrollment
156
Registered
2012-08-16
Start date
2009-09-30
Completion date
2017-06-30
Last updated
2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth, Length of NICU Stay, Oral Feeding Outcomes

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)

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?

Interventions

OTHERSOFFI

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.

Sponsors

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

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 5 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oral feeding outcomesUp to 3 monthsDefined 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.
Oral Feeding OutcomesUp to 5 monthsInfant oral feeding outcomes per structured parent phone interview at home.

Secondary

MeasureTime frameDescription
Growth outcomesUp to 3 monthsDefined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge
Growth OutcomesUp to 5 monthsGrowth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.

Other

MeasureTime frameDescription
Length of StayUp to 3 monthsLength of stay in days in the NICU
Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFIUp to 2 yearsMeasured 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026