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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
Must not have
Infants with a history of intestinal perforation or NEC
Infants with congenital anomalies, including but not limited to: Chromosomal abnormalities; Structural airway or pulmonary abnormalities (e.g. tracheoesophageal fistulas, cleft palate, congenital pulmonary adenomatous malformation, etc.); Abdominal anomalies requiring surgical interventions (e.g. intestinal atresia, intestinal webs, gastroschisis, omphalocele, anal atresia); Major cardiac anomalies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My infant had intestinal issues or NEC.
Select...
My infant has a birth defect, such as heart issues or structural problems.
Select...
My infant has not started eating by mouth within 10 days of birth.
Select...
My infant is on hydrocortisone for low blood pressure before being assigned to a study group.
Select...
My baby was born smaller than 90% of babies at the same number of weeks of pregnancy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of successful placements of duodenal tubes
Safety as assessed by number of intestinal perforations
Secondary study objectives
Central line days
Daily daily weight gain
Head circumference percentile at 36 weeks postmenstrual age
+16 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
45 Previous Clinical Trials
5,008,406 Total Patients Enrolled
Prem Fort, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital
Noura Nickel, MDPrincipal InvestigatorJohns Hopkins All Children's Hospital

Media Library

Mode of Delivery of Feeds Clinical Trial Eligibility Overview. Trial Name: NCT04246333 — N/A
Preterm Birth Research Study Groups: Duodenal Feeds, Gastric Feeds
Preterm Birth 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
~4 spots leftby Jun 2025
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