Duodenal Feeds in Very Low Birth Weight Infants

Launched by JOHNS HOPKINS ALL CHILDREN'S HOSPITAL · Jan 28, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a special way of feeding premature infants, particularly those who are very low birth weight (weighing less than 2.75 pounds) and may have breathing problems called bronchopulmonary dysplasia (BPD). The researchers want to see if feeding directly into the small intestine (called duodenal feeds) is safe and effective. This method might help reduce issues like stomach reflux, which can worsen breathing problems in these fragile babies. The study will focus on how well this feeding approach works compared to traditional feeding methods.

To participate in this trial, infants must be admitted to the Johns Hopkins All Children's Neonatal Intensive Care Unit (NICU) within the first 72 hours of life and have a birth weight of less than 1251 grams. However, some babies may not be eligible, such as those with certain birth complications or serious medical conditions. If eligible, participants can expect close monitoring and support from the medical team as they transition to this new feeding method. This trial aims to provide more safe feeding options for premature infants, helping them grow and recover better.

Gender

ALL

Eligibility 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