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Completed

NCT Number: NCT01666457

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

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?

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Key information

Conditions

Oral Feeding Outcomes Growth Length of NICU Stay

Age range

3 month–5 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOFFI

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.

Other names: Supporting Oral Feedings in Fragile Infants

Primary outcomes

  1. Oral feeding outcomes

    Time frame: Up to 3 months

    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.

  2. Oral Feeding Outcomes

    Time frame: Up to 5 months

    Infant oral feeding outcomes per structured parent phone interview at home.

Secondary outcomes

  1. Growth outcomes

    Time frame: Up to 3 months

    Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge

  2. Growth Outcomes

    Time frame: Up to 5 months

    Growth outcomes per parent report during phone interview at home include current weight to be reported as percentile on CDC growth chart.

Other outcomes

  1. Length of Stay

    Time frame: Up to 3 months

    Length of stay in days in the NICU

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

    Time frame: Up to 2 years

    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.

Sponsors and collaborators

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2017
First posted
Aug 16, 2012
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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