Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

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.

Study Overview

• Status: Completed
• Conditions: Swallowing Dysfunction
• Intervention / Treatment: Dietary supplement: Simply Thick

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Norfolk, Virginia, United States, 23501
      • Sentara Norfolk General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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; Other Names: Simply Thick®
No Intervention: Removal of thickener

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Elimination of symptoms associated with immature swallowing	2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Promotes transition to discharge from hospital	one week

Collaborators and Investigators

• Sponsor: David Oelberg, M.D.
• Investigators: Principal Investigator: David Oelberg, MD, Children's Hospital of the King's Daughters

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): September 1, 2010

Study Registration Dates

• First Submitted: March 9, 2009
• First Submitted That Met QC Criteria: March 9, 2009
• First Posted (Estimate): March 10, 2009

Study Record Updates

• Last Update Posted (Estimate): March 9, 2012
• Last Update Submitted That Met QC Criteria: March 7, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: 07-12-FB-0305