Trial Outcomes & Findings for Cold Milk for Dysphagia in Preterm Infants (NCT NCT04421482)

Last Updated: 2025-04-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

15-20 minutes post cold milk feeding

Results posted on

2025-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	22
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Physician Decision	1

Baseline Characteristics

Cold Milk for Dysphagia in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Very Low Birth Weight Preterm Infants n=21 Participants 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.
Age, Continuous	32 weeks gestation n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Very Low Birth Weight Preterm Infants n=12 Participants 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.
Percentage of Infants With Improvement of Dysphagia	58 Percentage of patients Interval 30.4 to 86.3

PRIMARY outcome

Timeframe: Post feeding (up to 5 minutes)

Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.

Outcome measures

Outcome measures
Measure	Very Low Birth Weight Preterm Infants n=21 Participants 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.
Axillary Temperature of Infants Post Room Temperature Feeding	98.2 Degrees fahrenheit Standard Deviation 0.3

PRIMARY outcome

Timeframe: 24 hours

Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.

Outcome measures

Outcome measures
Measure	Very Low Birth Weight Preterm Infants n=12 Participants 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.
Percentage of Infants With Change in Vital Signs Due to Cold Milk	0 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Very Low Birth Weight Preterm Infants n=5 Participants 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.
Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)	1.1 cm/s Interval -10.0 to 12.3

Adverse Events

Very Low Birth Weight Preterm Infants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nazeeh Hanna, MD

NYU Langone Health

Phone: 516-663-3853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place