CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 24 enrolled
Drug / intervention
Mode of Delivery of Feedsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04246333
NCT04246333N/ACompleted
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Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants

Johns Hopkins All Children's Hospital·interventional·Posted Jan 29, 2020·Updated Mar 18, 2026

In Brief

A clinical study evaluating Mode of Delivery of Feeds for BPD - Bronchopulmonary Dysplasia and 5 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Premature infants have high rates of bronchopulmonary dysplasia (BPD) due to prematurity of the participants' lungs and the need for prolonged respiratory support. These infants are at increased risk for gastroesophageal reflux and aspiration which may exacerbate lung injury. Transpyloric feeds, specifically duodenal feeds, may be used to bypass the stomach and directly feed the duodenum decreasing the amount of gastric reflux contributing to aspiration. Duodenal feeds are equivalent to gastric feeds with regards to nutritional outcomes, and have been shown to decrease events of apnea and bradycardia in premature infants. This study will evaluate the feasibility and safety of duodenal feeds in premature infants. The hypothesis is that duodenal feeds may be safely and successfully performed in premature very low birth weight infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBPD - Bronchopulmonary Dysplasia, VLBW - Very Low Birth Weight Infant, Feeding Disorder Neonatal, Feeding; Difficult, Newborn, Premature Birth, Chronic Lung Disease of Prematurity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 29, 2020
Enrollment StartAug 7, 2020
Primary CompletionFeb 19, 2026
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 6.4 years ago

Interventions

Mode of Delivery of Feedsother

Eligible infants will be recruited and enrolled and randomized to either duodenal feeds (DF) or gastric feeds (GF), which will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds. All enrolled infants will be fed per our institutional feeding protocol. Once infants advance past a volume of 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups.