Cold Milk for Dysphagia in Preterm Infants

Not Applicable

Completed

Conditions: Dysphagia of Newborn

Interventions: Other: Standard room temperature (RTS) feeding of milk/formula
Other: Cold temperature (CS, at 4-9°C) of milk/formula

Registration Number: NCT04421482

Lead Sponsor: NYU Langone Health

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 22

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Very Low Birth Weight Preterm Infants	Cold temperature (CS, at 4-9°C) of milk/formula	Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. (n=42)
Very Low Birth Weight Preterm Infants	Standard room temperature (RTS) feeding of milk/formula	Very Low Birth Weight Preterm Infants (birth weight less than 1,500g and less than 32 weeks gestation) admitted to NYU Winthrop NICU. (n=42)

Primary Outcome Measures

Name	Time	Method
Axillary Temperature of Infants Post Room Temperature Feeding	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	24 hours	Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.
Percentage of Infants With Improvement of Dysphagia	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.
Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)	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).