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Cold Milk for Dysphagia in Preterm Infants
NA trial testing Standard room temperature (RTS) feeding of milk/formula in Dysphagia of Newborn in 22 participants. Completed in 12 March 2024.
| Lead sponsor | NYU Langone Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 22 |
| Start date | 4 January 2021 |
| Primary completion | 12 March 2024 |
| Estimated completion | 12 March 2024 |
| Sites | 1 location across United States |
NYU Langone Health — full company profile →
35 Weeks and older, any sex, with Dysphagia of Newborn. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Very Low Birth Weight Preterm Infants | 58 | 30.4 – 86.3 |
Outcome measure will be assessed by measuring Axillary temperatures. The axillary temperature will be taken directly after feeding.
| Group | Value | 95% CI |
|---|---|---|
| Standard Room Temperature (RTS) Feeding of Milk/Formula (Control) | 98.2 | ± 0.3 |
Outcome measure will be assessed by monitoring changes in respiratory rate, heart rate, and oxygen saturation.
| Group | Value | 95% CI |
|---|---|---|
| Very Low Birth Weight Preterm Infants | 0 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Very Low Birth Weight Preterm Infants | 1.1 | -10 – 12.3 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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