Nutritive Sucking Patterns in Premature Infants

Premature Clinical Trial

Official title:

Nutritive Sucking Patterns in Premature Infants: A Randomized Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04561700
• Other study ID #: 300004412
• Status: Withdrawn
• Phase: N/A
• Start date: October 2021
• Est. completion date: June 2023

Study information

• Verified date: January 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Days

Eligibility

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

Related Conditions & MeSH terms

• Feeding Patterns
• Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified
• Malnutrition
• Premature
• Premature Birth

Intervention

Diagnostic Test:
• Reporting of sucking patterns captured by Instrumented Bottle
In the intervention group, data on nutritive sucking and feeding cues captured by the Instrumented Bottle will be made available to speech therapists to document the feeding session and provide written recommendations in their weekly report.
• Control
In the control group, the information captured by the Instrumented Bottle will not be made available to speech therapists and therefore, will not be used to document a feeding session or provide weekly recommendations.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to independent oral feeding	Time interval in days from introduction of oral feeding to full independent oral feeding	Birth to 120 days
Secondary	Postnatal age at discharge	Age in days at the time of hospital discharge	Birth to 120 days
Secondary	Length of hospital stay	Total number of hospitalization days	Birth to 120 days
Secondary	Growth rate during the transition from tube to oral feeding	Weekly weight gain in g/kg/day	Birth to 120 days
Secondary	Tube feeding events per day during the transition from tube to oral feeding.	Daily count of tube feeding events	Birth to 120 days