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NCT02030951 · ClinicalTrials.gov registry record
Measurement of Feeding Experience for Infants With Non-Oral Feedings
A clinical trial, sponsored by Medical College of Wisconsin.
- Terminated
- Registry status
- 27
- Enrollment target
NCT02030951: Clinical Trial study, sponsored by Medical College of Wisconsin.
NCT02030951 is a clinical trial that was terminated before completion, run by Medical College of Wisconsin. The registered enrollment target is 27 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02030951 was terminated before completion, sponsored by Medical College of Wisconsin.
- TERMINATED
- Registry status
- 27 participants
- Enrollment target
Study Summary
Feeding that circumvents the oral cavity drastically alters the infant's feeding experience (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that 35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral feeding, growth failure, and inadequate mother-infant interaction. Behaviors related to the feeding experience include behavioral state transitions, orally directed behaviors, hunger and satiation cues, and social interactive behaviors. It is unknown whether these early behaviors differ for hospitalized infants who receive long term tube feedings when compared with infants fed orally or whether alterations in these behaviors can be early indicators of later oral feeding difficulty. Documentation of these missing or altered behaviors is needed prior to the development and testing of interventions to prevent oral feeding difficulty. For 75 hospitalized infants with long term tube feedings, this research will: 1) describe the range of early feeding behaviors encompassing the feeding experience; 2) identify the change in early feeding behaviors throughout hospitalization; 3) compare the early feeding behaviors of infants with and without oral feeding difficulty at 12 months corrected age (CA); and 4) compare parent perception and provider assessment of feeding, for infants with and without oral feeding difficulty. We will document infant behaviors surrounding the feeding experience during tube feedings weekly during hospital stay. Throughout the first year of life, infant growth, parent perception and clinician assessment of infant feeding and infant and maternal behavior during feeding will be evaluated to document the occurrence of oral feeding difficulty, allowing for a comparison with early in hospital feeding behaviors. To analyze for changes over time, we will use Generalized Linear Mixed Models (GLMM) for repeated count (Poisson) and frequency/categorical (logistic and multinomial logistic) outc
Primary Outcome
Oral feeding difficulty will be identified through parent self report and clinician assessment at 2,4,6, and 12 months CA.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2014-01 |
| Est. Completion | 2015-08 |
Why NCT02030951 stopped before completion
NCT02030951 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 27 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02030951 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02030951 about?
NCT02030951 is a clinical study titled "Measurement of Feeding Experience for Infants With Non-Oral Feedings". Feeding that circumvents the oral cavity drastically alters the infant's feeding experience (pre, intra and post feeding) and may lead to oral feeding difficulty. It is estimated that 35 - 40% of infants exhibit oral feeding difficulty. Consequences include delayed oral feeding, growth failure, and ...
What is the current status of trial NCT02030951?
This trial is currently terminated. The enrollment target is 27 participants. The study started on 2014-01. Estimated completion is 2015-08.
Who is sponsoring clinical trial NCT02030951?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
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