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

Study Overview
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Brief Summary
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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: 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? 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? What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU? 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?

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

Conditions
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Growth, Oral Feeding Outcomes, Length of NICU Stay

Intervention / Treatment
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* Other: SOFFI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 5 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-SOFFI infants<br>Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff. | |
| Post SOFFI infants<br>Subject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and | Other: SOFFI<br>* 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.<br>* Other names: Supporting Oral Feedings in Fragile Infants;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Oral Feeding Outcomes | Infant oral feeding outcomes per structured parent phone interview at home. | Up to 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Supporting Oral Feeding in Fragile Infants (SOFFI), Infant Oral Feeding, Infant Growth, Preterm infant oral feeding, Preterm infant growth, Neonatal Intensive Care Unit (NICU)