Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Oelberg, M.D., Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT00859092
First received: March 9, 2009
Last updated: March 7, 2012
Last verified: March 2012
  Purpose

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.

Condition Intervention Phase
Swallowing Dysfunction
Dietary Supplement: Simply Thick
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Further study details as provided by Eastern Virginia Medical School:

Primary Outcome Measures:
  • Elimination of symptoms associated with immature swallowing [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Promotes transition to discharge from hospital [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2008
Study Completion Date: September 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thickening of feeds Dietary Supplement: Simply Thick
Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency
Other Name: Simply Thick®
No Intervention: Removal of thickener

  Eligibility

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. apneas and bradycardias with oral feedings
  2. oxygen desaturations with oral feedings
  3. excessive coughing or gagging with oral feedings

Exclusion Criteria:

  1. less than 32 weeks adjusted gestational age
  2. greater than 40 weeks adjusted gestational age
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00859092

Locations
United States, Virginia
Sentara Norfolk General Hospital
Norfolk, Virginia, United States, 23501
Sponsors and Collaborators
David Oelberg, M.D.
Investigators
Principal Investigator: David Oelberg, MD Children's Hospital of The King's Daughters
  More Information

No publications provided

Responsible Party: David Oelberg, M.D., Principal Investigator, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00859092     History of Changes
Other Study ID Numbers: 07-12-FB-0305
Study First Received: March 9, 2009
Last Updated: March 7, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 26, 2014