Measurement of Feeding Experience for Infants With Non-Oral Feedings

NCT02030951 | Terminated

• 1 other identifier: CHW 13/115
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Surgical Procedure

Keywords

preterm infant behavior; tube feeding; feeding efficiency

Outcome Measures

Primary Outcomes (1)

• Oral Feeding Difficulty

  Oral feeding difficulty will be identified through parent self report and clinician assessment at 2,4,6, and 12 months CA.

  12 months of life

Secondary Outcomes (1)

• Feeding progression

  over the first year of life

Other Outcomes (1)

• Parent Perception of oral feeding

  over the first year of life

Eligibility Criteria

• Age: Up to 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Children's Hospital and Health System Foundation, Wisconsin: collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53201, United States

Location

Study Officials

• Rosemary C. White-Traut, PhD

  Children's Hospital and Health System Foundation, Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nursing Research

Study Record Dates

• First Submitted: December 11, 2013
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

US (1)