Cold Milk for Dysphagia in Preterm Infants

Dysphagia of Newborn Clinical Trial

Official title:

Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04421482
• Other study ID #: 20-00876
• Secondary ID: R21HD100653
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: March 12, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Weeks and older

Eligibility

Inclusion Criteria:

1. VLBW (birth weight less than 1,500g and less than 32 weeks gestation)

2. admitted to NYU-Winthrop NICU

3. 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 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia of Newborn

Intervention

Other:
• Standard room temperature (RTS) feeding of milk/formula
Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions: standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.
• Cold temperature (CS, at 4-9°C) of milk/formula
Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions, standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Suck/swallow/breathe coordination	Measured by a non-invasive FDA approved equipment (nFant® Feeding Solution) during each of the two 15-20 minute feedings feediing conditions (RTS and CS, which will be done within the same day).	24 hours
Primary	Intestinal blood flow	Intestinal blood flow monitoring via Doppler ultrasound (Sonosite Edge Ultrasound system, Sonosite, Inc, WA) will be performed 6 times for each participant, performed one hour before and at 30 and 60 minutes after both bedside feeding conditions (RTS and CS, which will be done within the same day).	24 hours