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OpenTrials
Completed

NCT Number: NCT00859092

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.

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Key information

Conditions

Swallowing Dysfunction

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sentara Norfolk General Hospital

Norfolk, Virginia, 23501, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simply Thick

Dietary Supplement

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

Other names: Simply Thick®

Primary outcomes

  1. Elimination of symptoms associated with immature swallowing

    Time frame: 2 days

Secondary outcomes

  1. Promotes transition to discharge from hospital

    Time frame: one week

Sponsors and collaborators

Lead sponsor

David Oelberg, M.D.

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Mar 10, 2009
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.