Cold Milk for Dysphagia in Preterm Infants

NCT ID: NCT04421482

Last Updated: 2025-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2024-03-12

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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. 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.

Group Type: OTHER

Standard room temperature (RTS) feeding of milk/formula

Intervention Type: 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

Intervention Type: 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).

Interventions

Standard room temperature (RTS) feeding of milk/formula

Standard room temperature (RTS) milk/formula will be given for an entire feeding (15-20 minutes).

Intervention Type: OTHER

Cold temperature (CS, at 4-9°C) of milk/formula

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Viable preterm infants less than 34 weeks gestation

2. admitted to NYU- Langone Long Island Hospital NICU

3. PMA > 35 weeks at the time of the study

4. receiving no or minimum respiratory support (<2 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.

• Minimum Eligible Age: 35 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nazeeh Hanna

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40362766 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38947097 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21HD100653

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20-00876

Identifier Type: -

Identifier Source: org_study_id