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Measurement of Feeding Experience for Infants With Non-Oral Feedings

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02030951
Recruitment Status : Terminated (Funding completed)
First Posted : January 9, 2014
Last Update Posted : January 14, 2016
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Rosemary White-Traut, Medical College of Wisconsin

Brief 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) outcomes (e.g., frequency of infant behaviors). Understanding the constellation of these behaviors and when they begin, will guide the development of interventions whose goal will be to alleviate the long term consequences of oral feeding difficulty, inform clinical practice, and reduce cost.

Condition or disease
Complication of Surgical Procedure

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Feeding Experience for Infants With Non-Oral Feedings
Study Start Date : January 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Primary Outcome Measures :
  1. Oral Feeding Difficulty [ Time Frame: 12 months of life ]
    Oral feeding difficulty will be identified through parent self report and clinician assessment at 2,4,6, and 12 months CA.

Secondary Outcome Measures :
  1. Feeding progression [ Time Frame: over the first year of life ]
    Ability to feed orally

Other Outcome Measures:
  1. Parent Perception of oral feeding [ Time Frame: over the first year of life ]
    parents complete a survey on their perception of their infants' ability to feed orally

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Ages Eligible for Study:   up to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Seventy-five infants who are expected to receive a minimum of two weeks of non-oral formula/breast milk feedings during hospitalization and their mothers.

Infant Inclusion Criteria: * prior surgical treatment for gut,

  • chest surgery (non cardiac),
  • or non-surgical infants who will require a minimum of 2 weeks of non-oral formula/breast milk feedings,
  • may be receiving oxygen therapy and intravenous therapy.
  • may have previously been treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted ventilation. Maternal Inclusion criteria: *must be able to read and comprehend English. Infant Exclusion Criteria: *infant receiving assisted ventilation,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02030951

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United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53201
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
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Principal Investigator: Rosemary C. White-Traut, PhD Children's Hospital and Health System Foundation, Wisconsin
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Responsible Party: Rosemary White-Traut, Director of Nursing Research, Medical College of Wisconsin Identifier: NCT02030951    
Other Study ID Numbers: CHW 13/115
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 14, 2016
Last Verified: January 2016
Keywords provided by Rosemary White-Traut, Medical College of Wisconsin:
preterm infant behavior
tube feeding
feeding efficiency