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Clinical trial No longer in our active list Interventional Ages 0 Days to 12 Months

Using duodenal feeds for very low birth weight infants

Official title: Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants

Run by Johns Hopkins All Children's Hospital · NCT04246333 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if feeding very low birth weight infants through the duodenum instead of the stomach can help them grow better and avoid breathing problems.

Quick facts

Study typeInterventional
Ages0 Days to 12 Months
SexAll
Enrollment30 (estimated)
SponsorJohns Hopkins All Children's Hospital
Academic / other
Locations1 site (Saint Petersburg, Florida)
Trial IDNCT04246333 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants admitted to the NICU with a birth weight less than 1251 grams.

Probably not a fit

Patients with significant congenital anomalies or severe conditions at birth may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and feasibility of duodenal feeds in very low birth weight infants, who are at high risk for bronchopulmonary dysplasia (BPD) and related feeding disorders. Infants will be randomized to receive either continuous duodenal feeds or standard gastric feeds after reaching a certain volume of enteral feeds. The study aims to determine if duodenal feeds can reduce complications such as gastroesophageal reflux and aspiration, which may worsen lung injury. Outcomes will include measures of growth, respiratory support, and hospitalization.

Why it matters

Potential benefit: If successful, this approach could improve feeding tolerance and respiratory outcomes in very low birth weight infants.

How similar studies have gone: While the approach of using duodenal feeds is established, this specific application in very low birth weight infants is novel and has not been extensively tested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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

Where it's running

  • Johns Hopkins All Children's Hospital
    Saint Petersburg, Florida, United States     Recruiting

Study contacts

  • Principal investigator: Noura Nickel, MD — Johns Hopkins All Children's Hospital
  • Study coordinator: Noura Nickel, MD
  • Email: nnickel1@jh.edu
  • Phone: 727-767-4313

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.