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Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants
Sponsor study identifier
Secondary identifiers
NIH
interventional
22
1 country
1
Study Start
January 4, 2021
Actual (reported)Primary Completion
March 12, 2024
Actual (reported)Study Completion
March 12, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 12, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2020
Actual (reported)June 9, 2020
Actual (reported)January 4, 2021
Actual (reported)March 12, 2024
Actual (reported)March 12, 2024
Actual (reported)April 10, 2025
Actual (reported)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.
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.
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.
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).
Baseline (prior to feeding), 60 minutes after feeding
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.
Standard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes).
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).
NYU Langone Health
New York, New York, 10016, United States
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.
Ferrara 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.
Nazeeh Hanna
NYU Langone Health
22 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2020
First Posted
June 9, 2020
Study Start
January 4, 2021
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 12, 2024
Actual (reported)Study Completion
March 12, 2024
Actual (reported)Last Updated
April 10, 2025
Results First Posted
April 10, 2025
Record last verified: 2025-03
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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Source: ClinicalTrials.gov.
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