Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

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)

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15 participants in 2 patient groups

Thickening of feeds

Experimental group

Treatment:

Dietary Supplement: Simply Thick

Removal of thickener

No Intervention group