Cold Milk for Dysphagia in Preterm Infants

NCT04421482 | Completed Results DMC

• 2 other identifiers: 20-00876R21HD100653
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysphagia of Newborn

Outcome Measures

Primary Outcomes (4)

• Percentage of Infants With Improvement of Dysphagia

  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.

  15-20 minutes post cold milk feeding

• Axillary Temperature of Infants Post Room Temperature Feeding

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

  Post feeding (up to 5 minutes)

• Percentage of Infants With Change in Vital Signs Due to Cold Milk

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

  24 hours

• Change in Peak Systolic Velocity (PSV) (60 Minutes Post 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).

  Baseline (prior to feeding), 60 minutes after feeding

Study Arms (1)

Very Low Birth Weight Preterm Infants

OTHER

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.

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

Interventions

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).

Very Low Birth Weight Preterm Infants

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).

Very Low Birth Weight Preterm Infants

Eligibility Criteria

• Age: 35 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• Ferrara-Gonzalez L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk to Preterm Infants with Uncoordinated Oral Feeding Patterns. Nutrients. 2025 Apr 26;17(9):1457. doi: 10.3390/nu17091457.

  PMID: 40362766 DERIVED

• Ferrara L, Kamity R, Htun Z, Dumpa V, Islam S, Hanna N. From Warm to Cold: Feeding Cold Milk in Preterm Infants with Uncoordinated Oral Feeding Patterns. Res Sq [Preprint]. 2024 Jun 18:rs.3.rs-4504972. doi: 10.21203/rs.3.rs-4504972/v1.

  PMID: 38947097 DERIVED

MeSH Terms

Interventions

Cold Temperature

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Results Point of Contact

• Title: Nazeeh Hanna, MD
• Organization: NYU Langone Health

Nazeeh.hanna@nyulangone.org

516-663-3853

Study Officials

• Nazeeh Hanna

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective study, with each infant serving as their own control. The order of each condition will be randomized to control for fatigue

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: January 4, 2021
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: April 10, 2025
• Results First Posted: April 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

US (1)