Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Swallowing Dysfunction Clinical Trial

Official title:

Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00859092
• Other study ID #: 07-12-FB-0305
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2009
• Last updated: March 7, 2012
• Start date: March 2008
• Est. completion date: September 2010

Study information

• Verified date: March 2012
• Source: Eastern Virginia Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Swallowing Dysfunction

Intervention

Dietary Supplement:
• Simply Thick
Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency

Locations

Country	Name	City	State
United States	Sentara Norfolk General Hospital	Norfolk	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
David Oelberg, M.D.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Elimination of symptoms associated with immature swallowing		2 days	No
Secondary	Promotes transition to discharge from hospital		one week	No