Nutritive Sucking Patterns in Premature Infants

Not Applicable

Withdrawn

• Conditions: Premature; Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified; Feeding Patterns
• Interventions: Diagnostic Test: Control; Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle

• Registration Number: NCT04561700
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

Detailed 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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2020-09-05
• Study First Submitted QC: 2020-09-19
• Study First Posted: 2020-09-24
• Study Start: 2021-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-10
• Primary Completion: 2022-07
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)
Reporting of sucking patterns captured by Instrumented Bottle	Reporting of sucking patterns captured by Instrumented Bottle	Weekly reporting on objective measurements of sucking activity during oral feeding

Primary Outcome Measures

Name	Time	Method
Time to independent oral feeding	Birth to 120 days	Time interval in days from introduction of oral feeding to full independent oral feeding

Secondary Outcome Measures

Name	Time	Method
Length of hospital stay	Birth to 120 days	Total number of hospitalization days
Postnatal age at discharge	Birth to 120 days	Age in days at the time of hospital discharge
Growth rate during the transition from tube to oral feeding	Birth to 120 days	Weekly weight gain in g/kg/day
Tube feeding events per day during the transition from tube to oral feeding.	Birth to 120 days	Daily count of tube feeding events