CompletedNot Applicable

Duodenal Feeds in Very Low Birth Weight Infants

United States24 participantsStarted 2020-08-07

Plain-language 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.

Who can participate

Age range0 Days – 12 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of successful placements of duodenal tubes

Timeframe: 12 months

Safety as assessed by number of intestinal perforations

Timeframe: 12 months

Trial details

NCT IDNCT04246333

SponsorJohns Hopkins All Children's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-19