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Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00859092
First Posted: March 10, 2009
Last Update Posted: March 9, 2012
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.
Information provided by (Responsible Party):
David Oelberg, M.D., Eastern Virginia Medical School
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Further study details as provided by David Oelberg, M.D., Eastern Virginia Medical School:

Primary Outcome Measures:
  • Elimination of symptoms associated with immature swallowing [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Promotes transition to discharge from hospital [ Time Frame: one week ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: March 9, 2009
First Posted: March 10, 2009
Last Update Posted: March 9, 2012
Last Verified: March 2012