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Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

NCT00859092 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-03-09

No results posted yet for this study

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.

Conditions

  • Swallowing Dysfunction

Interventions

DIETARY_SUPPLEMENT

Simply Thick

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

Sponsors & Collaborators

  • David Oelberg, M.D.

    lead OTHER

Principal Investigators

  • David Oelberg, MD · Children's Hospital of The King's Daughters

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-06-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00859092 on ClinicalTrials.gov