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Feeding Practices for Premature Infants

N/A

Recruiting

Led By Rajeev Kumar, MD

Research Sponsored by Rajeev Kumar

Eligibility Criteria Checklist

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

Must have

Preterm Infants 24-34 weeks of gestation

On Non-invasive ventilation (NIPPV/CPAP/HFNC)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomization until the date of nicu discharge/death, assessed up to 1 year.

Awards & highlights

Study Summary

This trial compares two methods of feeding preterm babies on non-invasive respiratory support to see which is faster to reach full feeds.

Who is the study for?

This trial is for preterm infants between 24-34 weeks of gestation who are not eating by mouth or only receiving minimal feeds and require non-invasive breathing support. Infants with major birth defects, those on invasive ventilation, or older than 34 weeks gestational age cannot participate.Check my eligibility

What is being tested?

The study aims to determine the best feeding method for premature babies needing respiratory support. It compares two approaches: giving food in small amounts at intervals (intermittent bolus feeds) versus a steady flow of nutrition (continuous feeds).See study design

What are the potential side effects?

While the trial focuses on feeding practices rather than medications, potential side effects may include digestive issues such as intolerance to feedings, abdominal distension, or complications related to their prematurity and respiratory status.

Eligibility Criteria

Inclusion Criteria

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

Select...

My baby was born between 24 and 34 weeks of pregnancy.

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I am using a machine to help with my breathing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomization until the date of nicu discharge/death, assessed up to 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomization until the date of nicu discharge/death, assessed up to 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomization until the date of nicu discharge/death, assessed up to 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Day of life to reach full feeds

Secondary outcome measures

Feeding interruptions

Length of hospital stay

Time to reach (day of life) first oral feed

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Continuous FeedingExperimental Treatment1 Intervention

Continuous feeding will be defined as delivering enteral nutrition with constant speed for 24 hours via a nutritional pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g).

Group II: Bolus FeedingExperimental Treatment1 Intervention

Intermittent bolus feeding will be defined as delivering enteral nutrition multiple times, usually every 2-3 hours over 15 - 30 minutes by gravity or an electric pump. It will be further stratified as per weight ( less than 1000 g, 1000-1500 g, >1500 g).

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rajeev KumarLead Sponsor

Rajeev Kumar, MDPrincipal InvestigatorCook County Health

2 Previous Clinical Trials

100 Total Patients Enrolled

Media Library

Method of feeding Clinical Trial Eligibility Overview. Trial Name: NCT05824377 — N/A

Premature Birth Research Study Groups: Bolus Feeding, Continuous Feeding

Premature Birth Clinical Trial 2023: Method of feeding Highlights & Side Effects. Trial Name: NCT05824377 — N/A

Method of feeding 2023 Treatment Timeline for Medical Study. Trial Name: NCT05824377 — 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 vacancies available in this experiment for prospective participants?

"This experiment, which was first launched on February 1st 2023, is currently enrolling patients. Clinicaltrials.gov indicates that the data concerning this study was most recently amended on April 11th 2023."

Answered by AI

What would be the uppermost limit of participants in this trial?

"Affirmative. On clinicaltrials.gov, the evidence suggests that this medical trial is currently seeking participants. It opened for recruitment on February 1st 2023 and was last updated on April 11th of the same year; its intent is to enrol 46 patients at a single location."

Answered by AI

Recent research and studies

Journal of PerinatologyJournal

The Effects of Oral Feeding While on Nasal Continuous Positive Airway Pressure (NCPAP) in Preterm Infants

Dumpa, Vikramaditya, Ranjith Kamity, Louisa Ferrara, Meredith Akerman, and Nazeeh Hanna. 2020. “The Effects of Oral Feeding While on Nasal Continuous Positive Airway Pressure (NCPAP) in Preterm Infants”. Journal of Perinatology. Springer Science and Business Media LLC. doi:10.1038/s41372-020-0632-2.

clinicaltrials.govStudy

To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.

Rajeev Kumar 2023. "To Determine the Best Feeding Practice in Preterm Infants on Non-invasive Ventilation.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05824377.