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Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00859092
Enrollment
15
Registered
2009-03-10
Start date
2008-03-31
Completion date
2010-09-30
Last updated
2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Swallowing Dysfunction

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.

Interventions

DIETARY_SUPPLEMENTSimply Thick

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

Sponsors

David Oelberg, M.D.
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 3 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Elimination of symptoms associated with immature swallowing2 days

Secondary

MeasureTime frame
Promotes transition to discharge from hospitalone week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026