Skip to main content
Clinical Trials/NCT00859092
NCT00859092
Completed
Phase 2

Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

David Oelberg, M.D.1 site in 1 country15 target enrollmentMarch 2008

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Swallowing Dysfunction
Sponsor
David Oelberg, M.D.
Enrollment
15
Locations
1
Primary Endpoint
Elimination of symptoms associated with immature swallowing
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.

Hypotheses:

  • Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
  • Thickened feeds will promote transition to hospital discharge.
Registry
clinicaltrials.gov
Start Date
March 2008
End Date
September 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
David Oelberg, M.D.
Responsible Party
Sponsor Investigator
Principal Investigator

David Oelberg, M.D.

Principal Investigator

Eastern Virginia Medical School

Eligibility Criteria

Inclusion Criteria

  • apneas and bradycardias with oral feedings
  • oxygen desaturations with oral feedings
  • excessive coughing or gagging with oral feedings

Exclusion Criteria

  • less than 32 weeks adjusted gestational age
  • greater than 40 weeks adjusted gestational age

Outcomes

Primary Outcomes

Elimination of symptoms associated with immature swallowing

Time Frame: 2 days

Secondary Outcomes

  • Promotes transition to discharge from hospital(one week)

Study Sites (1)

Loading locations...

Similar Trials