Infant, Very Low Birth WeightNCT06569186
Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants
A study testing Cue-based feedings in people with Infant, Very Low Birth Weight and Infant Development, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant, Very Low Birth Weight, Infant Development, Feeding Patterns
- What is being tested?
- Cue-based feedings
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Oct 2028
- 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birthweight < 1500 grams
- Gestational age between 28 and 31 weeks of gestation
- Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
- Oral feeding initiated before 33 weeks PMA.
Who cannot join
- Major congenital/chromosomal anomalies,
- Patent ductus arteriosus causing significant cardiovascular symptoms
- History of necrotizing enterocolitis stage 2 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial
In this parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.
- Being tested
- Cue-based feedings
- Medical subject headings
- Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cue-based feedingsBehavioural
Also called Speech therapy driven feeds
Speech therapists will use cue-based protocols to guide feeds
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Cue-based feedings Receives: Behavioral: Cue-based feedings |
| Control | No intervention | Clinician based feedings |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time interval in days from introduction to attainment of independent oral feeding
Measured: 4-20 days
Secondary outcomes (5)
Postnatal age at discharge in days
Measured: 34 to 40 weeks postnatal age
Length of hospital stay in days
Measured: 10-60 days
Average weight gain during the transition from tube to oral feeding
Measured: 10-60 days
Total number of tube feeding events per infant during the transition from tube to oral feeding
Measured: 10-60 days
Follow up phone call
A follow-up phone call 3 months after NICU discharge will also be performed to assess long-term outcomes including the need for tube feeding or hospitalizations related to feeding/nutrition problems.
Measured: 4-6 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2024
- Study startDec 2026 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionOct 2028 (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 Infant, Very Low Birth WeightStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and Control groups
- Masking
- None (open label)
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569186
- Sponsor's protocol ID
- IRB-300012540
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cue-Based Vs. Clinician-Driven Feeding in Very Low Birthweight Infants: A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT06569186
- Acronym / sponsor ID
- IRB-300012540
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 23 Aug 2024 (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 parallel-group randomized controlled trial, very low birthweight infants will be randomly assigned in a 1:1 ratio to either cue-based (intervention group) or clinician-driven feeding (control group). For infants in the intervention group, Speech therapists and nurses will use their cue-based assessment training to aid in clinical management of oral feeding. For infants in the control group, clinicians caring for these infants will define the feeding plan based on their daily assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and Control groups
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Behavioral: Cue-based feedingsCue-based feedings |
| Control | No intervention | –Clinician based feedings |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Birthweight < 1500 grams
- Gestational age between 28 and 31 weeks of gestation
- Full enteral feeding established before 32 weeks of postmenstrual age (PMA)
- Oral feeding initiated before 33 weeks PMA.
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 |
|---|---|---|
| Cue-based feedingsAlso: Speech therapy driven feedsSpeech therapists will use cue-based protocols to guide feeds | Behavioural | Intervention |
Primary outcome
Time interval in days from introduction to attainment of independent oral feeding
Time frame: 4-20 days
5 secondary outcomes
Postnatal age at discharge in days
Time frame: 34 to 40 weeks postnatal age
Length of hospital stay in days
Time frame: 10-60 days
Average weight gain during the transition from tube to oral feeding
Time frame: 10-60 days
Total number of tube feeding events per infant during the transition from tube to oral feeding
Time frame: 10-60 days
Follow up phone call
Time frame: 4-6 months after birth
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 27 Aug 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cue-based feedings in people with Infant, Very Low Birth Weight and Infant Development, run by University of Alabama at Birmingham at 1 site in United States.
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 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 interval in days from introduction to attainment of independent oral feeding (time frame: 4-20 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 27 Aug 2026.