Nutritive Sucking Patterns in Premature Infants

The University of Alabama at Birmingham

Status: Withdrawn

Conditions: Premature; Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified; Feeding Patterns

Treatments: Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle; Diagnostic Test: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT04561700

300004412

Details and patient eligibility

About

In this pilot trial, the investigators will determine the feasibility of monitoring nutritive sucking patterns to facilitate the transition from tube to oral feeding in extremely-low-birth weight (ELBW) infants

Full description

In this parallel-group randomized controlled trial, ELBW infants (birthweight < 1000 grams) will be randomly assigned in a 1:1 ratio to either weekly reporting on objective measurements of sucking activity during oral feeding (intervention group) or usual care without information on sucking activity (control group).

Sex: All

Ages: 7 to 60 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Birthweight < 1000 grams
• Gestational age < 32 weeks of gestation
• Full enteral feeding established before or on postnatal day 21
• Oral feeding initiated before or at 33 weeks of postmenstrual age

Exclusion criteria

• Major congenital/chromosomal anomalies
• Patent ductus arteriosus causing significant cardiovascular symptoms
• History of necrotizing enterocolitis stage 2 or greater

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Reporting of sucking patterns captured by Instrumented Bottle

Experimental group

Description:

Weekly reporting on objective measurements of sucking activity during oral feeding

Treatment:

Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle

Control

Sham Comparator group

Description:

Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)

Treatment:

Diagnostic Test: Control