Duodenal Feeds in Very Low Birth Weight Infants

NCT04246333 | Completed DMC

• 1 other identifier: IRB00217658
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BPD - Bronchopulmonary Dysplasia; VLBW - Very Low Birth Weight Infant; Feeding Disorder Neonatal; Feeding; Difficult, Newborn; Premature Birth; Chronic Lung Disease of Prematurity

Keywords

Duodenal feeds; Transpyloric feeds; Bronchopulmonary Dysplasia; BPD; Premature infant; Neonate

Outcome Measures

Primary Outcomes (2)

• Number of successful placements of duodenal tubes

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

  12 months

• Safety as assessed by number of intestinal perforations

  Safety of duodenal feeds in very low birth weight infants as measured by the number of intestinal perforations secondary to placement of duodenal tube.

  12 months

Secondary Outcomes (20)

• Supplemental oxygen requirement

  duration of hospitalization, up to 15 months

• Number of participants with Bronchopulmonary Dysplasia

  15 months

• Number of deaths during hospitalization

  15 months

• Number of days of mechanical ventilation

  15 months

• Number of participants with late-onset sepsis

  15 months

Study Arms (2)

Gastric Feeds

NO INTERVENTION

Patients in this arm will receive feeds via the standard route which is gastric feeds.

Duodenal Feeds

EXPERIMENTAL

Patients in this arm will receive feeds via the experimental route which is duodenal feeds.

Other: Mode of Delivery of Feeds

Interventions

Mode of Delivery of Feeds OTHER

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.

Duodenal Feeds

Eligibility Criteria

• Age: 0 Days - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants admitted to the Johns Hopkins All Children's NICU before 72 hours of life
• Infants with a birth weight \<1251g

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins All Children's Hospital: lead

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Noura Nickel, MD

  Johns Hopkins All Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 29, 2020
• Study Start: August 7, 2020
• Primary Completion: February 19, 2026
• Study Completion: February 19, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)