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NCT04246333 · ClinicalTrials.gov registry record · NA

Duodenal Feeds in Very Low Birth Weight Infants

A NA study, sponsored by Johns Hopkins All Children's Hospital.

Completed
Registry status
NA
Development phase
24
Enrollment target

NCT04246333: Completed NA study, sponsored by Johns Hopkins All Children's Hospital.

NCT04246333 is a NA study that has completed, run by Johns Hopkins All Children's Hospital. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04246333, a NA study, has completed, sponsored by Johns Hopkins All Children's Hospital.

COMPLETED
Registry status
NA
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

Success to be measured by appropriate placement of the duodenal tube within the duodenum as confirmed by radiographic imaging.

Interventions

  • OTHER Mode of Delivery of Feeds

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2020-08-07
Est. Completion 2026-02-19
Phase NA

What the finished NCT04246333 record still lists

NCT04246333 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

The record links to 0 conditions, and to 1 intervention - of which Mode of Delivery of Feeds is the first listed.

NCT04246333 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04246333 about?

NCT04246333 is a clinical study titled "Duodenal Feeds in Very Low Birth Weight Infants". 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, spe...

What is the current status of trial NCT04246333?

This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2020-08-07. Estimated completion is 2026-02-19.

What interventions are being tested in trial NCT04246333?

The interventions under investigation include: Mode of Delivery of Feeds (OTHER).

Who is sponsoring clinical trial NCT04246333?

This trial is sponsored by Johns Hopkins All Children's Hospital, which has 24 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04246333's enrollment target sits among peer trials

24 1736th of 2000 higher than 246 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04246333, the US trial registry maintained by the National Library of Medicine. NCT04246333 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.