← Back to Search

Cold Milk for Swallowing Disorders in Preterm Infants

Q: Are there still opportunities to participate in this research endeavor?

<p>Affirmative. As evidenced by the info found on clinicaltrials.gov, this medical study is at present enlisting individuals for participation. Initially posted on April 1st 2021 and last revised November 28th 2022, the trial seeks 42 participants from a single location.</p>

Q: What is the total number of participants involved in this experiment?

<p>Affirmative. According to the information available from clinicaltrials.gov, this trial is currently recruiting participants after being initially posted on April 1st 2021 and subsequently updated November 28th 2022. It requires 42 patients for its single study site.</p>

N/A

Waitlist Available

Led By Nazeeh Hanna

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving no or minimum respiratory support (<1 lit/min low-flow nasal cannula)

Having symptoms of swallowing dysfunction during oral feeding (clinical dysphagia)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial will help researchers understand if cold milk can help with dysphagia, a swallowing disorder, in premature infants.

Who is the study for?

This trial is for very low birth weight preterm infants in the NYU-Winthrop NICU, who are over 35 weeks post-menstrual age, can handle at least half of their feeding by mouth, and show signs of swallowing difficulty. Infants must be on minimal respiratory support and referred for a swallow study. Those with growth issues, airway anomalies, brain injuries, neuromuscular diseases or severe congenital conditions cannot join.Check my eligibility

What is being tested?

The study tests if feeding preterm infants cold milk (4-9°C) helps manage dysphagia better than standard room temperature milk. It aims to see if cold milk improves coordination during sucking/swallowing/breathing and reduces risk of food entering the airway without affecting intestinal blood flow as checked by Doppler Ultrasound.See study design

What are the potential side effects?

Potential side effects may include reactions to cold milk such as changes in intestinal blood flow; however, this trial hypothesizes that there will be no adverse effects based on preliminary data.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need little to no help with breathing.

Select...

I have trouble swallowing when I eat.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intestinal blood flow

Suck/swallow/breathe coordination

Trial Design

1Treatment groups

Experimental Treatment

Group I: Very Low Birth Weight Preterm InfantsExperimental Treatment2 Interventions

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)

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

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

1,963 Previous Clinical Trials

2,674,719 Total Patients Enrolled

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,739 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,566 Total Patients Enrolled

Media Library

Cold Milk Clinical Trial Eligibility Overview. Trial Name: NCT04421482 — N/A

Swallowing Difficulty Research Study Groups: Very Low Birth Weight Preterm Infants

Swallowing Difficulty Clinical Trial 2023: Cold Milk Highlights & Side Effects. Trial Name: NCT04421482 — N/A

Cold Milk 2023 Treatment Timeline for Medical Study. Trial Name: NCT04421482 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to participate in this research endeavor?

"Affirmative. As evidenced by the info found on clinicaltrials.gov, this medical study is at present enlisting individuals for participation. Initially posted on April 1st 2021 and last revised November 28th 2022, the trial seeks 42 participants from a single location."

Answered by AI

What is the total number of participants involved in this experiment?

"Affirmative. According to the information available from clinicaltrials.gov, this trial is currently recruiting participants after being initially posted on April 1st 2021 and subsequently updated November 28th 2022. It requires 42 patients for its single study site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cold Milk for Dysphagia in Preterm Infants

2021. "Cold Milk for Dysphagia in Preterm Infants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04421482.