Cold Milk for Dysphagia in Preterm Infants

Cold Milk as a Novel Therapy 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 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.

Study Overview

• Status: Completed
• Conditions: Dysphagia of Newborn
• Intervention / Treatment: Other: Standard room temperature (RTS) feeding of milk/formula; Other: Cold temperature (CS, at 4-9°C) of milk/formula

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nazeeh Hanna, MD; Phone Number: 516-663-3853; Email: Nazeeh.hanna@NYULangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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. (n=42)

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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Nazeeh Hanna, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): March 12, 2024
• Study Completion (Actual): March 12, 2024

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: 20-00876; R21HD100653 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: Nazeeh.hanna@NYULangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal may direct requests to Nazeeh.hanna@NYULangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No