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New feeding method aims to protect premature Babies' lungs

NCT ID NCT04246333

Knowledge-focused Sponsor: Johns Hopkins All Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether feeding very low birth weight premature infants directly into the duodenum (the first part of the small intestine) is safe and doable. The goal is to reduce stomach reflux that can worsen lung damage. Twenty-four infants were randomly assigned to receive either standard stomach feeds or duodenal feeds. The researchers measured how often the feeding tube was placed correctly and checked for complications like intestinal perforation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Duodenal feeding (feeding tube placed in the duodenum)
What this could lead to
If successful, this approach could offer a safer way to feed very premature infants, potentially reducing lung damage from reflux.
What could go wrong
This is a small, early feasibility study with only 24 infants, so results may not apply broadly. There is a risk of intestinal perforation from tube placement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Aug 2020

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 days to 12 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life * Infants with a birth weight \<1251g Exclusion Criteria: * First obtained pH \<7.0 * APGAR \<5 at 5 minutes (The Apgar score is a test given to newborns soon after birth. This test checks a baby's heart rate, muscle tone, and other signs to see if extra medical care or emergency care is needed. Appearance, Pulse, Grimace, Activity, Respiration (APGAR)) * Infants on hydrocortisone for hypotension prior to randomization * Infants with intrauterine growth restriction (IUGR) defined by birth weight ≤10th percentile for gestational age * 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 * Infants with a history of intestinal perforation or NEC * Presence of gastrostomy tube * Infants who have not been initiated on any volume of enteral feeds by 10 days of life

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Conditions

The condition(s) this trial relates to.

bronchopulmonary dysplasia Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

BPD - bronchopulmonary dysplasia Chronic lung disease of prematurity Feeding disorder neonatal Feeding; difficult, newborn Premature birth VLBW - very low birth weight infant

Contacts and locations

Locations

  • Johns Hopkins All Children's Hospital

    St. Petersburg, Florida, 33701, United States

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