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

NCT ID: NCT01666457

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2017-06-30

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:

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

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Conditions

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Oral Feeding Outcomes Growth Length of NICU Stay

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-SOFFI infants

Infants discharged from the NICU prior to the implementation of the SOFFI infant driven feeding program with NICU staff.

No interventions assigned to this group

Post SOFFI infants

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

SOFFI

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Supporting Oral Feedings in Fragile Infants

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ann & Robert H Lurie Children's Hospital of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Susan M Horner, MS, APN/CNS, RNC-NIC

Developmental Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan M Horner, MS

Role: PRINCIPAL_INVESTIGATOR

Ann & Robert H Lurie Children's Hospital of Chicago

Locations

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Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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2009-13949 Horner

Identifier Type: -

Identifier Source: org_study_id

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