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Completed

NCT Number: NCT04421482

Cold Milk 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.

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.

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Key information

Age range

35 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Standard room temperature (RTS) feeding of milk/formula

Other

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/formula

Other

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).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 9, 2020
Registry last updated
Apr 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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