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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 08/05/2020.

Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Clinicaltrials.gov identifier NCT00859092

Recruitment Status Completed

First Posted March 10, 2009

Last update posted March 9, 2012

Study Description

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.

  • Condition or Disease:Swallowing Dysfunction
  • Intervention/Treatment: Dietary Supplement: Simply Thick
  • Phase: Phase 2
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 15 participants
  • 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
  • Study Start Date: March 2008
  • Actual Primary Completion Date: June 2009
  • Actual Study Completion Date: September 2010
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • Primary Outcome Measures: 1. Elimination of symptoms associated with immature swallowing [ Time Frame: 2 days ]
  • Secondary Outcome Measures: 1. Promotes transition to discharge from hospital [ Time Frame: one week ]
Eligibility Criteria
  • Ages Eligible for Study: up to 3 / (Birth to 17 years)
  • 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
Contacts
Locations

United States, Virginia
Sentara Norfolk General Hospital
Norfolk

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.
  • ClinicalTrials.gov Identifier: NCT00859092 History of Changes
  • Other Study ID Numbers: 07-12-FB-0305
  • First Posted: March 10, 2009 Key Record Dates
  • Last Update Posted: March 9, 2012
  • Last Verified: March 2012