PrematureNCT04561700
Nutritive Sucking Patterns in Premature Infants
A study testing Reporting of sucking patterns captured by Instrumented Bottle in people with Premature and Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, run by University of Alabama at Birmingham.
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 Read more about this study
- Who is it for?
- Ages 7 to 60 days
- Conditions the study is for
- Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns
- What is being tested?
- Reporting of sucking patterns captured by Instrumented Bottle
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Major congenital/chromosomal anomalies
- Patent ductus arteriosus causing significant cardiovascular symptoms
- History of necrotizing enterocolitis stage 2 or greater
About this study
Official title: 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
Read the 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).
- Conditions
- Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns
- Being tested
- Reporting of sucking patterns captured by Instrumented Bottle, Control
- Medical subject headings
- Premature Birth, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reporting of sucking patterns captured by Instrumented BottleDiagnostic test
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.
ControlDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Reporting of sucking patterns captured by Instrumented Bottle | Experimental | Weekly reporting on objective measurements of sucking activity during oral feeding Receives: Diagnostic Test: Reporting of sucking patterns captured by Instrumented Bottle |
| Control | Sham comparator | Weekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported) Receives: Diagnostic Test: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to independent oral feeding
Time interval in days from introduction of oral feeding to full independent oral feeding
Measured: Birth to 120 days
Secondary outcomes (4)
Postnatal age at discharge
Age in days at the time of hospital discharge
Measured: Birth to 120 days
Length of hospital stay
Total number of hospitalization days
Measured: Birth to 120 days
Growth rate during the transition from tube to oral feeding
Weekly weight gain in g/kg/day
Measured: Birth to 120 days
Tube feeding events per day during the transition from tube to oral feeding.
Daily count of tube feeding events
Measured: Birth to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study startOct 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJun 2023 (estimated)
Why it stopped: Unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ariel A. Salas, University of Alabama at Birmingham
- Investigators
- Ariel A. Salas, MD, MSPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561700
- Sponsor's protocol ID
- 300004412
- Status last verified
- Jan 2022
- First submitted
- 5 Sep 2020
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritive Sucking Patterns in Premature Infants: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04561700
- Acronym / sponsor ID
- 300004412
- Conditions
- Premature, Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, Feeding Patterns
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Oct 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reporting of sucking patterns captured by Instrumented Bottle | Experimental | Diagnostic Test: Reporting of sucking patterns captured by Instrumented BottleWeekly reporting on objective measurements of sucking activity during oral feeding |
| Control | Sham comparator | Diagnostic Test: ControlWeekly reporting on traditional measurements of sucking activity during oral feeding (no objective measurements reported) |
Who may qualify
- Ages
- 7 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Major congenital/chromosomal anomalies
- Patent ductus arteriosus causing significant cardiovascular symptoms
- History of necrotizing enterocolitis stage 2 or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reporting of sucking patterns captured by Instrumented BottleIn 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. | Diagnostic test | Reporting of sucking patterns captured by Instrumented Bottle |
| ControlIn 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. | Diagnostic test | Control |
Primary outcome
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
4 secondary outcomes
Postnatal age at discharge
Time frame: Birth to 120 days
Length of hospital stay
Time frame: Birth to 120 days
Growth rate during the transition from tube to oral feeding
Time frame: Birth to 120 days
Tube feeding events per day during the transition from tube to oral feeding.
Time frame: Birth to 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ariel A. Salas, MD, MSPH principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Reporting of sucking patterns captured by Instrumented Bottle in people with Premature and Light-For-Dates Without Mention of Fetal Malnutrition, Unspecified, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to independent oral feeding (time frame: Birth to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.