Promotion of Thickened Feeds to Manage Newborns With Feed... | NCT00859092

Studies
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

NCT00859092

Sponsor

David Oelberg, M.D.

Status

Completed

Last Update Posted

Mar 9, 2012Estimated

Enrollment

15Estimated

Phase

Phase 2

Conditions

Swallowing Dysfunction

Interventions

Simply Thick

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 9, 2009

First Submission Date that Met QC Criteria

Mar 9, 2009

First Posted Date

Mar 10, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Thickening of feeds	Experimental		Dietary Supplement: Simply Thick
Removal of thickener	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Simply Thick	Dietary Supplement	Simply Thick® added to each bottle of formula or beast milk to create nectar or honey consistency	Thickening of feeds

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

apneas and bradycardias with oral feedings
oxygen desaturations with oral feedings
excessive coughing or gagging with oral feedings

Exclusion Criteria:

less than 32 weeks adjusted gestational age
greater than 40 weeks adjusted gestational age

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
David Oelberg, MD	Children's Hospital of The King's Daughters	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sentara Norfolk General Hospital		Norfolk	Virginia	23501	United States