NCT01666457

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. 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. 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. 3.What is the impact of implementing the SOFFI on the length of stay of medically fragile infants in the NICU?
  4. 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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 13, 2012

Last Update Submit

August 16, 2018

Conditions

Oral Feeding OutcomesGrowthLength of NICU Stay

Keywords

Supporting Oral Feeding in Fragile Infants (SOFFI)Infant Oral FeedingInfant GrowthPreterm infant oral feedingPreterm infant growthNeonatal Intensive Care Unit (NICU)

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Growth outcomes

    Up to 3 months

  • Growth Outcomes

    Up to 5 months

Other Outcomes (2)

  • Length of Stay

    Up to 3 months

  • Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI

    Up to 2 years

Study Arms (2)

Pre-SOFFI infants

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

Post SOFFI infants

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

Other: SOFFI

Interventions

SOFFIOTHER

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.

Also known as: Supporting Oral Feedings in Fragile Infants
Post SOFFI infants

Eligibility Criteria

Age3 Months - 5 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Study Officials

  • Susan M Horner, MS

    Ann & Robert H Lurie Children's Hospital of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Developmental Specialist

Study Record Dates

First Submitted

August 13, 2012

First Posted

August 16, 2012

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

June 30, 2017

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)