Clinical trial NCT04421482: Cold Milk for Dysphagia in Preterm Infants
Official title: Cold Milk as a Novel Therapy for Dysphagia in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphagia of Newborn
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-06-09
Enrollment: 22
Sex: ALL
Minimum age (years): 35
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Percentage of Infants With Improvement of Dysphagia
timeFrame: 15-20 minutes post cold milk feeding
measure: Axillary Temperature of Infants Post Room Temperature Feeding
timeFrame: Post feeding (up to 5 minutes)
measure: Percentage of Infants With Change in Vital Signs Due to Cold Milk
timeFrame: 24 hours
measure: Change in Peak Systolic Velocity (PSV) (60 Minutes Post Feeding)
timeFrame: Baseline (prior to feeding), 60 minutes after feeding
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nazeeh Hanna
role: PRINCIPAL_INVESTIGATOR
References: