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 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-04
• Study First Posted: 2020-06-09
• Study Start: 2021-01-04
• Status Verified: 2024-03
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-29
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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Exclusion Criteria

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

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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
Intestinal blood flow	24 hours	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).
Suck/swallow/breathe coordination	24 hours	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).

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States