Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

NCT ID: NCT00859092

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Conditions

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Swallowing Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Thickening of feeds

Group Type EXPERIMENTAL

Simply Thick

Intervention Type DIETARY_SUPPLEMENT

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

Removal of thickener

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Simply Thick

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Simply Thick®

Eligibility Criteria

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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
Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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David Oelberg, M.D.

OTHER

Sponsor Role lead

Responsible Party

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David Oelberg, M.D.

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Oelberg, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of The King's Daughters

Locations

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Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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07-12-FB-0305

Identifier Type: -

Identifier Source: org_study_id

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