Nutritive Sucking Patterns in Premature Infants

January 6, 2022 updated by: Ariel A. Salas, University of Alabama at Birmingham

Nutritive Sucking Patterns in Premature Infants: A Randomized Trial

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reporting of sucking patterns captured by Instrumented Bottle
Weekly reporting on objective measurements of sucking activity during oral feeding
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.
Sham Comparator: Control
Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported)
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to independent oral feeding
Time Frame: Birth to 120 days
Time interval in days from introduction of oral feeding to full independent oral feeding
Birth to 120 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

September 5, 2020

First Submitted That Met QC Criteria

September 19, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

January 10, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300004412

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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