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Cold Milk for Dysphagia in Preterm Infants

Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04421482
Enrollment
22
Registered
2020-06-09
Start date
2021-01-04
Completion date
2024-03-12
Last updated
2025-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia of Newborn

Brief 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. 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.

Interventions

OTHERStandard room temperature (RTS) feeding of milk/formula

Standard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes).

OTHERCold temperature (CS, at 4-9°C) of milk/formula

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).

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention 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

Eligibility

Sex/Gender
ALL
Age
35 Weeks to No maximum
Healthy volunteers
No

Inclusion criteria

1. Viable preterm infants less than 34 weeks gestation 2. admitted to NYU- Langone Long Island Hospital NICU 3. PMA \> 35 weeks at the time of the study 4. receiving no or minimum respiratory support (\<2 lit/min low-flow nasal cannula) 5. tolerating at least 50% of their enteral feeding orally and 6. having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia). 7. referred by the medical team for VFSS and/or FEES assessments.

Exclusion criteria

Infants with other comorbidities, such as IUGR, upper airway anomalies, brain injury, neuromuscular disease, or life-threatening congenital disease.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Infants With Improvement of Dysphagia15-20 minutes post cold milk feedingDysphagia 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 FeedingPost 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 Milk24 hoursOutcome 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)Baseline (prior to feeding), 60 minutes after feedingOutcome 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
Very Low Birth Weight Preterm Infants
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.
21
Total21

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision1

Baseline characteristics

CharacteristicVery Low Birth Weight Preterm Infants
Age, Continuous32 weeks gestation
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
4 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
12 Participants
Region of Enrollment
United States
21 participants
Sex: Female, Male
Female
10 Participants
Sex: Female, Male
Male
11 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 21
other
Total, other adverse events
0 / 21
serious
Total, serious adverse events
0 / 21

Outcome results

Primary

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.

Time frame: Post feeding (up to 5 minutes)

ArmMeasureValue (MEAN)Dispersion
Very Low Birth Weight Preterm InfantsAxillary Temperature of Infants Post Room Temperature Feeding98.2 Degrees fahrenheitStandard Deviation 0.3
Primary

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).

Time frame: Baseline (prior to feeding), 60 minutes after feeding

Population: The outcome measure was not collected after the first five infants, as the analysis showed no significant change. As a result, there was no justification for continuing data collection or subjecting the remaining infants to the procedure.

ArmMeasureValue (MEAN)
Very Low Birth Weight Preterm InfantsChange in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)1.1 cm/s
Primary

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.

Time frame: 24 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Very Low Birth Weight Preterm InfantsPercentage of Infants With Change in Vital Signs Due to Cold Milk0 Participants
Primary

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.

Time frame: 15-20 minutes post cold milk feeding

Population: Infants were assessed post room temp milk feeding for dysphagia. If they showed signs of dysphagia, they would receive cold milk. Therefore only infants showing dysphagia either by FEES or VFSS were included in the analysis, as not all infants received cold milk during this assessment.

ArmMeasureValue (NUMBER)
Very Low Birth Weight Preterm InfantsPercentage of Infants With Improvement of Dysphagia58 Percentage of patients

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026