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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)

This study has been completed.
Sponsor:
Collaborator:
Ann & Robert H Lurie Children
Information provided by (Responsible Party):
Susan M Horner, MS, APN/CNS, RNC-NIC, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT01666457
First received: August 13, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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?

Condition Intervention
Oral Feeding Outcomes
Growth
Length of NICU Stay
Other: SOFFI

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU

Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • Oral feeding outcomes [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    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.

  • Oral Feeding Outcomes [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    Infant oral feeding outcomes per structured parent phone interview at home.


Secondary Outcome Measures:
  • Growth outcomes [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge

  • Growth Outcomes [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]
    Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.


Other Outcome Measures:
  • Length of Stay [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]
    Length of stay in days in the NICU

  • Change in NICU staff evaluations and communications r/t infants' oral feeding pre-SOFFI to post-SOFFI [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Measured 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.


Enrollment: 156
Study Start Date: September 2009
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.
Other Name: Supporting Oral Feedings in Fragile Infants

  Eligibility

Ages Eligible for Study:   3 Months to 5 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666457

Locations
United States, Illinois
Ann & Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Ann & Robert H Lurie Children
Investigators
Principal Investigator: Susan M Horner, MS Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: Susan M Horner, MS, APN/CNS, RNC-NIC, Developmental Specialist, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT01666457     History of Changes
Other Study ID Numbers: 2009-13949 Horner
Study First Received: August 13, 2012
Last Updated: August 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Supporting Oral Feeding in Fragile Infants (SOFFI)
Infant Oral Feeding
Infant Growth
Preterm infant oral feeding
Preterm infant growth
Neonatal Intensive Care Unit (NICU)

ClinicalTrials.gov processed this record on November 27, 2014