Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Phase 2

Completed

• Conditions: Swallowing Dysfunction
• Interventions: Dietary Supplement: Simply Thick

• Registration Number: NCT00859092
• Lead Sponsor: David Oelberg, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-03-09
• Study First Submitted QC: 2009-03-09
• Study First Posted: 2009-03-10
• Primary Completion: 2009-06
• Study Completion: 2010-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Thickening of feeds	Simply Thick	-

Primary Outcome Measures

Name	Time	Method
Elimination of symptoms associated with immature swallowing	2 days

Secondary Outcome Measures

Name	Time	Method
Promotes transition to discharge from hospital	one week

Trial Locations

Locations (1)

Sentara Norfolk General Hospital; 🇺🇸 Norfolk, Virginia, United States