This study will evaluate the efficacy and safety of 2 dose levels of NTRA-2112 on intestinal malabsorption in preterm infants as compared to placebo. NTRA-2112 is a powder of insulin formulation for reconstitution in breast milk, infant formula, normal and half-normal saline administered with the preterm infant's formula, donor breast milk, or own mother's breast milk for local gastrointestinal (GI) therapy. The effect on intestinal malabsorption will be evaluated by comparing the ability of preterm infants to achieve full enteral (EN) feeding for 3 consecutive days.
The study will enroll preterm infants weighing at least 500g born between 26 and 32 weeks of pregnancy who meet inclusion and exclusion criteria. Infants will be treated for 28 days or until discharged from the hospital, whichever happens first. Patients will be randomly-assigned to one of three treatment arms: Treatment A 400 ?U/ml ? equivalent dose of insulin or NTRA-2112; Treatment B to
obtain 2000 ?U/ml dose of insulin; or placebo as calculated according to planned daily enteral intake. During the treatment period, infants will undergo daily evaluation of nutrition, general growth, gastric residuals, development progression, and any side effects.
Patients will be evaluated at day of discharge along with follow-up clinic visits performed at 3 months, 12 months, and 24 months corrected age.
The Sponsor is conducting a clinical study with STP206 for the prevention of Necrotizing Enterocolitis (NEC) in preterm infants weighing less than 4.4 lbs. (2000g). NEC is the most common serious disease of the gut in preterm infants. The purpose of this study is to look at the safety of STP206 in babies born early, and to get early information on whether STP206 may prevent NEC.
STP206 is an investigational product, meaning it is not yet approved by the US Food and Drug Administration for use in the United States. STP206 contains live bacteria and is considered a Live Biotherapeutic. The two types of bacteria are Lactobacillus and Bifidobacteria. These bacteria are used in foods such as cheese, yogurt, sauerkraut, and pickles, and have been consumed safely for years and are commonly contained in probiotic products that are currently sold throughout the world. These bacteria also are normally present in parts of the body such as bowel, mouth, skin, and the vagina. These bacteria generally do not cause disease. There have been studies of probiotic bacteria in premature babies that suggest these types of bacteria are effective in preventing NEC. The purpose of this study is to determine the safety of STP206 and if it is effective in preventing NEC.
A program has been created to provide this specialized preterm infant/mother outpatient lactation support. Titled "Promoting Lactation Education, Access and Support Efforts for Preterm Infants" (PLEASE for preterm infants), it includes (1) equipment availability and (2) pediatric clinic-based lactation counseling support. To determine the effectiveness and implementation of this program in a real-world environment requires evaluation in a racially, socioeconomically, and geographically diverse population. The eight-county coastal area of SC provides that diversity. Through the SC Pediatric Practice Research Network (SCPPRN), the effectiveness of the program will be studied through 14 pediatric care clinics