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Feed Warming for Preterm Infants' Tube Feeding Tolerance

N/A

Waitlist Available

Research Sponsored by Advocate Center for Pediatric Research

Eligibility Criteria Checklist

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

Must have

Preterm infants born at less than or equal to 30 0/7 weeks gestation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 168 completed feedings; approximately 28 days

Awards & highlights

Study Summary

This trial is looking at whether using a water bath or a commercial warmer to heat milk for preterm infants affects the infants' ability to tolerate the feedings.

Who is the study for?

This trial is for preterm infants born at less than or equal to 30 weeks gestation. They must be enrolled within the first 48 hours of life and stay in the study for at least 28 days. Infants with gastrointestinal anomalies, lethal malformations, or without parental consent are excluded.Check my eligibility

What is being tested?

The study tests how warming milk affects feeding tolerance in premature babies. It compares two methods: a water bath versus a commercial warmer. Eighty-six infants will be randomly assigned to one of these groups, and their progress towards full feeds will be monitored.See study design

What are the potential side effects?

Since this trial involves feeding methods rather than medication, traditional side effects aren't expected. However, potential risks may include variations in feeding tolerance such as differences in gastric residual volume.

Eligibility Criteria

Inclusion Criteria

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

Select...

My baby was born at or before 30 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 completed feedings; approximately 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~168 completed feedings; approximately 28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 completed feedings; approximately 28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Feeding intolerance

Secondary outcome measures

Full enteral feeding

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Commercial warmerExperimental Treatment1 Intervention

Feedings warmed with a commercial warmer

Group II: Standard warmingActive Control1 Intervention

Feeding warmed in water bath

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Advocate Center for Pediatric ResearchLead Sponsor

1 Previous Clinical Trials

78 Total Patients Enrolled

Advocate Health CareOTHER

53 Previous Clinical Trials

1,510,895 Total Patients Enrolled

Medela AGIndustry Sponsor

17 Previous Clinical Trials

1,669 Total Patients Enrolled

Media Library

Feedings warmed with commercial warmer Clinical Trial Eligibility Overview. Trial Name: NCT02034903 — N/A

Tube Feeding Research Study Groups: Standard warming, Commercial warmer

Tube Feeding Clinical Trial 2023: Feedings warmed with commercial warmer Highlights & Side Effects. Trial Name: NCT02034903 — N/A

Feedings warmed with commercial warmer 2023 Treatment Timeline for Medical Study. Trial Name: NCT02034903 — N/A

Frequently Asked Questions

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

Are any fresh participants being welcomed into this clinical trial?

"The information on clinicaltrials.gov attests that this medical trial is not presently recruiting patients and the last update to it was made in January of 2014. Nevertheless, there are 7 other studies with open enrollment at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation

Bonnie Satinover 2013. "Effect of Feed Warming Method on Feeding Tolerance in the Preterm Infant Born at Less Than 30 Weeks Gestation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02034903.

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