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Transpyloric Feeding for Very Low Birth Weight Infants

N/A
Recruiting
Led By Prem Fort, MD
Research Sponsored by Johns Hopkins All Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants with a birth weight <1251g
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights

Study Summary

This trial will evaluate the feasibility and safety of transpyloric feeds in premature infants. The hypothesis is that transpyloric feeds may be safely and successfully performed in premature very low birth weight infants.

Who is the study for?
This trial is for premature infants weighing less than 1251 grams at birth, admitted to the NICU within 72 hours of life. It's not suitable for babies who haven't started feeding by day 10, those on certain medications, with growth restrictions, very low APGAR scores, intestinal issues or congenital anomalies.Check my eligibility
What is being tested?
The study tests if duodenal feeds (bypassing the stomach to feed directly into the small intestine) can be done safely and effectively in very low birth weight infants to reduce lung complications associated with prematurity and traditional gastric feeding methods.See study design
What are the potential side effects?
While specific side effects are not listed here, potential risks may include discomfort from tube placement and possible nutritional differences compared to standard gastric feeds. The safety assessment will monitor any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born weighing less than 1251 grams.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of successful placements of duodenal tubes
Safety as assessed by number of intestinal perforations
Secondary outcome measures
Central line days
Daily daily weight gain
Head circumference percentile at 36 weeks postmenstrual age
+17 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Duodenal FeedsExperimental Treatment1 Intervention
Patients in this arm will receive feeds via the experimental route which is duodenal feeds.
Group II: Gastric FeedsActive Control1 Intervention
Patients in this arm will receive feeds via the standard route which is gastric feeds.

Find a Location

Who is running the clinical trial?

Johns Hopkins All Children's HospitalLead Sponsor
42 Previous Clinical Trials
5,007,213 Total Patients Enrolled
Prem Fort, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital

Media Library

Mode of Delivery of Feeds Clinical Trial Eligibility Overview. Trial Name: NCT04246333 — N/A
Very Low Birth Weight Infant Research Study Groups: Duodenal Feeds, Gastric Feeds
Very Low Birth Weight Infant Clinical Trial 2023: Mode of Delivery of Feeds Highlights & Side Effects. Trial Name: NCT04246333 — N/A
Mode of Delivery of Feeds 2023 Treatment Timeline for Medical Study. Trial Name: NCT04246333 — N/A

Frequently Asked Questions

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

Is the recruitment phase of this clinical trial still active?

"Records on clinicaltrials.gov indicate that this experiment is actively recruiting test subjects, having initially been posted on August 7th 2020 and subsequently revised on June 6th 2022."

Answered by AI

Which patient demographic is authorized to participate in this experiment?

"Currently, 30 neonates are being accepted for this trial; to be eligible, babies must have been born prematurely and fall within the 0 Day - 12 Month age range."

Answered by AI

How many participants is the maximum capacity for this clinical trial?

"Affirmative. According to the information provided through clinicaltrials.gov, this particular medical experiment is actively looking for participants from a single trial location and has opened recruitment since its initial posting on August 7th of 2020. The most recent update occurred on June 6th 2022 and the study seeks 30 patients in total."

Answered by AI

Does this research endeavor accept elderly participants?

"This clinical trial is limited to participants between 0 days and 12 months old. 335 studies are available for individuals who have not yet reached the age of majority, while 478 trials can be accessed by seniors aged 65 or older."

Answered by AI
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~2 spots leftby Jun 2024