Oral Feeding OutcomesNCT01666457
Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the Neonatal ICU (NICU)
An observational study of Oral Feeding Outcomes and Growth, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 months
- Conditions the study is for
- Oral Feeding Outcomes, Growth, Length of NICU Stay
- What is being tested?
- SOFFI
- Type of treatment
- Pill or oral medicine
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 months
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Childrens Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the 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:
- 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?
- Conditions
- Oral Feeding Outcomes, Growth, Length of NICU Stay
- Being tested
- SOFFI
- Keywords
- Supporting Oral Feeding in Fragile Infants (SOFFI), Infant Oral Feeding, Infant Growth, Preterm infant oral feeding, Preterm infant growth, Neonatal Intensive Care Unit (NICU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOFFIOther
Also called Supporting Oral Feedings in Fragile Infants
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: SOFFI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months
Oral Feeding Outcomes
Infant oral feeding outcomes per structured parent phone interview at home.
Measured: Up to 5 months
Secondary outcomes (2)
Growth outcomes
Defined as an infant's height, weight and length percentiles on the Center for Disease Control (CDC) growth chart at NICU discharge
Measured: 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.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Feeding OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan M Horner, MS, APN/CNS, RNC-NIC, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Susan M Horner, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01666457
- Sponsor's protocol ID
- 2009-13949 Horner
- Other IDs
- 2009
- Status last verified
- Aug 2018
- First submitted
- 13 Aug 2012
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Implementing an Infant Driven Feeding Program on Oral Feeding and Growth Outcomes of Medically Fragile Infants in the NICU
- ClinicalTrials.gov ID
- NCT01666457
- Acronym / sponsor ID
- 2009-13949 Horner
- Conditions
- Oral Feeding Outcomes, Growth, Length of NICU Stay
- Keywords
- Supporting Oral Feeding in Fragile Infants (SOFFI), Infant Oral Feeding, Infant Growth, Preterm infant oral feeding, Preterm infant growth, Neonatal Intensive Care Unit (NICU)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 16 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: SOFFISubject infants discharged from the NICU at least 6 months after the implementation of the SOFFI infant driven feeding program and |
Who may qualify
- Ages
- 3 to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Infants of all gestations and diagnostic groups in this tertiary level NICU will be included in the sample
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOFFIAlso: Supporting Oral Feedings in Fragile InfantsNICU 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 | Post SOFFI infants |
Primary outcome
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.
Oral Feeding Outcomes
Time frame: Up to 5 months
Infant oral feeding outcomes per structured parent phone interview at home.
2 secondary outcomes
Growth outcomes
Time frame: Up to 3 months
Growth Outcomes
Time frame: Up to 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Horner, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Feeding Outcomes and Growth, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral feeding outcomes (time frame: Up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.