Dysphagia of NewbornNCT04421482
Cold Milk for Dysphagia in Preterm Infants
A study testing Standard room temperature (RTS) feeding of milk/formula and Cold temperature (CS, at 4-9°C) of milk/formula in people with Dysphagia of Newborn, run by NYU Langone Health at 1 site in United States.
Trial summary
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Dysphagia of Newborn
- What is being tested?
- Standard room temperature (RTS) feeding of milk/formula and Cold temperature (CS, at 4-9°C) of milk/formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 12 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Viable preterm infants less than 34 weeks gestation
- admitted to NYU- Langone Long Island Hospital NICU
- PMA > 35 weeks at the time of the study
- receiving no or minimum respiratory support (<2 lit/min low-flow nasal cannula)
- tolerating at least 50% of their enteral feeding orally and
- having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia).
- referred by the medical team for VFSS and/or FEES assessments.
Who cannot join
- Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury, neuromuscular disease, or life-threatening congenital disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic airway compromise results in a persistent inflammatory state, with disease progression that can be devastating for already fragile and developmentally immature lungs in preterm infants. At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral feeding. In a recent publication, our research group was the first to demonstrate that short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%. However, these data must be further validated for the effectiveness and safety of a full duration feeding before being recommended for routine clinical practice.
The objective is to identify preliminary evidence for the efficacy and safety of feeding full oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe coordination and decrease penetration/ aspiration to the airway. We further hypothesize that cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by Doppler Ultrasound. This is significant because there is a critical need to identify effective and safe evidence-based treatment options for dysphagia management in preterm infants.
Read more
This prospective study will seek to enroll Subjects who meet the following inclusion criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2) admitted to NYU-Winthrop Neonatal Intensive Care Unit (NICU), 3) Post-menstrual age (PMA) > 35 weeks at the time of the study, 4) receiving no or minimum respiratory support (<1 lit/min low-flow nasal cannula), 5) tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing (FEES).
To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a doppler ultrasound before and after the ingestion of cold liquid feeding to assess the mesenteric blood flow.
- Conditions
- Dysphagia of Newborn
- Being tested
- Standard room temperature (RTS) feeding of milk/formula, Cold temperature (CS, at 4-9°C) of milk/formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard room temperature (RTS) feeding of milk/formulaOther
Standard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes).
Cold temperature (CS, at 4-9°C) of milk/formulaOther
If the infant shows signs of dysphagia cold temperature (CS, at 4-9°C) milk/formula will be given for an entire feeding (15-20 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Very Low Birth Weight Preterm Infants | Other | Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. Infants will first receive room temperature milk and then be assessed for signs of dysphagia. Only infants that show signs of dysphagia will receive cold milk. Receives: Other: Standard room temperature (RTS) feeding of milk/formula; Other: Cold temperature (CS, at 4-9°C) of milk/formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Infants With Improvement of Dysphagia
Dysphagia will be assessed by Video Fluoroscopic Swallow Study (VFSS) and/or Fiberoptic Endoscopic Evaluation of Swallowing (FEES). If the infants showed signs of dysphagia they would receive cold cold milk and improvements in dysphagia would be assessed again by VFSS and FEES.
Measured: 15-20 minutes post cold milk feeding
Axillary Temperature of Infants Post Room Temperature Feeding
Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.
Measured: Post feeding (up to 5 minutes)
Percentage of Infants With Change in Vital Signs Due to Cold Milk
Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.
Measured: 24 hours
Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)
Outcome measure will be assessed by abdominal ultrasound. Peak systolic velocity (PSV) was measured for each patient before feeding (room temp or cold milk) as well as 60 minutes after feeding (room temp and cold milk).
Measured: Baseline (prior to feeding), 60 minutes after feeding
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start4 Jan 2021
- Primary completion12 Mar 2024
- Study completion12 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dysphagia of NewbornStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Nazeeh Hanna, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421482
- Sponsor's protocol ID
- 20-00876
- Other IDs
- R21HD100653
- Status last verified
- Mar 2025
- First submitted
- 4 Jun 2020
- Last updated
- 10 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Nazeeh.hanna@NYULangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Ferrara-Gonzalez L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk to Preterm Infants with Uncoordinated Oral Feeding Patterns. Nutrients. 2025 Apr 26;17(9):1457. doi: 10.3390/nu17091457.
PubMed 40362766Ferrara L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk in Preterm Infants with Uncoordinated Oral Feeding Patterns. Res Sq [Preprint]. 2024 Jun 18:rs.3.rs-4504972. doi: 10.21203/rs.3.rs-4504972/v1.
PubMed 38947097
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants
- ClinicalTrials.gov ID
- NCT04421482
- Acronym / sponsor ID
- 20-00876
- Conditions
- Dysphagia of Newborn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 12 Mar 2024 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 10 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is estimated that 30-70% of very low birth weight (VLBW) preterm infants will be diagnosed with swallowing dysfunction (dysphagia), which often leads to airway compromise in the form of laryngeal penetration and/or tracheal aspiration during oral feeding attempts. Chronic airway compromise results in a persistent inflammatory state, with disease progression that can be devastating for already fragile and developmentally immature lungs in preterm infants. At this time, there are limited therapeutic options for dysphagia in VLBW infants during oral feeding. In a recent publication, our research group was the first to demonstrate that short-duration of oral feeding with cold liquid reduces dysphagia occurrence from 71% to 26%. However, these data must be further validated for the effectiveness and safety of a full duration feeding before being recommended for routine clinical practice.
The objective is to identify preliminary evidence for the efficacy and safety of feeding full oral cold milk for dysphagia management in preterm infants. We hypothesize that oral feeding of cold milk in VLBW preterm infants with dysphagia will improve suck/swallow/breathe coordination and decrease penetration/ aspiration to the airway. We further hypothesize that cold milk intervention will have no adverse effects on intestinal blood flow, as assessed by Doppler Ultrasound. This is significant because there is a critical need to identify effective and safe evidence-based treatment options for dysphagia management in preterm infants.
This prospective study will seek to enroll Subjects who meet the following inclusion criteria: 1) VLBW (birth weight less than 1,500g and less than 32 weeks gestation), 2) admitted to NYU-Winthrop Neonatal Intensive Care Unit (NICU), 3) Post-menstrual age (PMA) > 35 weeks at the time of the study, 4) receiving no or minimum respiratory support (<1 lit/min low-flow nasal cannula), 5) tolerating at least 50% of their enteral feeding orally, 6) having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia) and 7) referred by the medical team for video fluoroscopic swallow study (VFSS) and/or fiberoptic endoscopic evaluation of swallowing (FEES).
To assess the efficacy of cold milk in treating dysphagia, study subjects will first have an oral motor feeding assessment using an FDA approved device called the nFant® Feeding Solution as well as VFSS and/or FEES. To assess the safety of using cold milk, subjects will receive a doppler ultrasound before and after the ingestion of cold liquid feeding to assess the mesenteric blood flow.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue
| Arm | Type | Receives |
|---|---|---|
| Very Low Birth Weight Preterm Infants | Other | Other: Standard room temperature (RTS) feeding of milk/formula, Other: Cold temperature (CS, at 4-9°C) of milk/formulaVery Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. Infants will first receive room temperature milk and then be assessed for signs of dysphagia. Only infants that show signs of dysphagia will receive cold milk. |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Viable preterm infants less than 34 weeks gestation
- admitted to NYU- Langone Long Island Hospital NICU
- PMA > 35 weeks at the time of the study
- receiving no or minimum respiratory support (<2 lit/min low-flow nasal cannula)
- tolerating at least 50% of their enteral feeding orally and
Key exclusion criteria (1 listed)
- Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury, neuromuscular disease, or life-threatening congenital disease.
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 |
|---|---|---|
| Standard room temperature (RTS) feeding of milk/formulaStandard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes). | Other | Very Low Birth Weight Preterm Infants |
| Cold temperature (CS, at 4-9°C) of milk/formulaIf the infant shows signs of dysphagia cold temperature (CS, at 4-9°C) milk/formula will be given for an entire feeding (15-20 minutes). | Other | Very Low Birth Weight Preterm Infants |
Primary outcome
Percentage of Infants With Improvement of Dysphagia
Time frame: 15-20 minutes post cold milk feeding
Dysphagia will be assessed by Video Fluoroscopic Swallow Study (VFSS) and/or Fiberoptic Endoscopic Evaluation of Swallowing (FEES). If the infants showed signs of dysphagia they would receive cold cold milk and improvements in dysphagia would be assessed again by VFSS and FEES.
Axillary Temperature of Infants Post Room Temperature Feeding
Time frame: Post feeding (up to 5 minutes)
Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.
Percentage of Infants With Change in Vital Signs Due to Cold Milk
Time frame: 24 hours
Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.
Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)
Time frame: Baseline (prior to feeding), 60 minutes after feeding
Outcome measure will be assessed by abdominal ultrasound. Peak systolic velocity (PSV) was measured for each patient before feeding (room temp or cold milk) as well as 60 minutes after feeding (room temp and cold milk).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40362766Ferrara-Gonzalez L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk to Preterm Infants with Uncoordinated Oral Feeding Patterns. Nutrients. 2025 Apr 26;17(9):1457. doi: 10.3390/nu17091457.
- Derived from this study: PubMed 38947097Ferrara L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk in Preterm Infants with Uncoordinated Oral Feeding Patterns. Res Sq [Preprint]. 2024 Jun 18:rs.3.rs-4504972. doi: 10.21203/rs.3.rs-4504972/v1.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Nazeeh.hanna@NYULangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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.
Nazeeh Hanna principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard room temperature (RTS) feeding of milk/formula and Cold temperature (CS, at 4-9°C) of milk/formula in people with Dysphagia of Newborn, run by NYU Langone Health 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 7 inclusion and 1 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: finished, as of the sponsor's last update on 10 Apr 2025. 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?
Yes. Results are posted in the registry (first posted 10 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Infants With Improvement of Dysphagia (time frame: 15-20 minutes post cold milk feeding). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421482, which also lists 2 linked publications.
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 Apr 2025.