Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

D

David Oelberg, M.D.

Status and phase

Completed
Phase 2

Conditions

Swallowing Dysfunction

Treatments

Dietary Supplement: Simply Thick

Study type

Interventional

Funder types

Other

Identifiers

NCT00859092
07-12-FB-0305

Details and patient eligibility

About

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.

Enrollment

15 estimated patients

Sex

All

Ages

Under 3 months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups

Thickening of feeds
Experimental group
Treatment:
Dietary Supplement: Simply Thick
Removal of thickener
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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