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NCT04421482 · ClinicalTrials.gov registry record · NA
Cold Milk for Dysphagia in Preterm Infants
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 22
- Enrollment target
NCT04421482 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 22 participants.
The verdict
NCT04421482, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 22 participants
- Enrollment target
Study 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 sym
Interventions
- OTHER Standard room temperature (RTS) feeding of milk/formula
- OTHER Cold temperature (CS, at 4-9°C) of milk/formula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2024-03-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04421482
The ClinicalTrials.gov registry entry for NCT04421482 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Standard room temperature (RTS) feeding of milk/formula is the first listed.
NCT04421482 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04421482 about?
NCT04421482 is a clinical study titled "Cold Milk 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 result...
What is the current status of trial NCT04421482?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2021-01-04. Estimated completion is 2024-03-12.
What interventions are being tested in trial NCT04421482?
The interventions under investigation include: Standard room temperature (RTS) feeding of milk/formula (OTHER), Cold temperature (CS, at 4-9°C) of milk/formula (OTHER).
Who is sponsoring clinical trial NCT04421482?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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