Using duodenal feeds for very low birth weight infants
Feasibility and Safety of Duodenal Feeds in Very Low Birth Weight Infants
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 0 Days to 12 Months |
| Sex | All |
| Sponsor | Johns Hopkins All Children's Hospital Academic / other |
| Locations | 1 site (Saint Petersburg, Florida) |
| Trial ID | NCT04246333 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are infants admitted to the NICU with a birth weight less than 1251 grams.
Not a fit: Patients with significant congenital anomalies or severe conditions at birth may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Saint Petersburg, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.