Programs + Services
The Newborn Medicine Division at Tufts Medical Center in Boston provides comprehensive care to newborns from top neonatologists, nurses, and staff.
More information about programs and services
The Neonatal Intensive Care Unit at Tufts Medical Center in Boston provides comprehensive care to critically ill newborns.
More information about programs and services
Research + Clinical Trials
Premature infants can get a serious inflammatory condition, called necrotizing enterocolitis (NEC), that damages parts of the intestines. It is the most common cause of illness of the intestinal tract in premature infants in the first few weeks of life. It is a very serious condition that can lead to death in up to half of affected infants. There is no way to predict whether an infant will get NEC, and there are no reliable early warning signals. There is no established preventive treatment for NEC. Infants with NEC are usually treated with bowel rest (stopping feeding by mouth), antibiotic medicines, and in some cases with surgery where the affected bowel needs to be removed.
Some studies have shown that live bacteria given to the intestine of premature infants as early as possible in their life might be able to prevent NEC. Researchers want to find out if an investigational drug called “IBP-9414”, which is made of living bacteria, can help prevent NEC in prematurely born infants. An investigational drug is a drug that is being tested and is not approved for use and sale by any authorities (like the U.S Food and Drug Administration [FDA], the European Medicines Agency [EMA], or the authority in your country
All infants in the study will receive “standard-of-care” treatment, which means they will receive the same medical treatment they would receive if they were not in the study. In addition to the standard-of-care treatment that all infants will receive, half of the infants in the study will receive the investigational drug (IBP-9414) and half will receive an inactive substance (contains no medicine) called “placebo”. Receiving placebo is the same as not receiving any medication other than the standard-of-care treatment. The reason placebo is used in this study is to help the researchers know if any effects they see in the study are because of the investigational drug rather than the researchers’ expectations about the effects of the study drug. Neither you nor the study doctor/staff will be able to choose or to know whether your child receives IBP 9414 or placebo. This is why the study is called “double blind”. Your child will be assigned at random (like flipping a coin) to receive IBP 9414 or placebo. Your child’s chances of receiving IBP 9414 or placebo are the same (50 50 chance). In case of medical need, the study doctor will be able to find out whether your child is receiving IBP 9414 or placebo. In this study, the placebo will be sterile water. Please ask the study doctor or study staff if you have any questions about your child receiving placebo.
The main purpose of this study is to see if IBP-9414 can prevent NEC and if it is safe and tolerable. The unit that doses of live bacterial drugs are measured in is called “colony forming units” or CFUs. The dose of IBP-9414 to be tested is 1x109 CFU, which means it contains 1 billion live bacteria. This dose has been tested previously in a smaller study of IBP-9414 and was found to be safe and tolerable. In order to see if this dose actually can prevent NEC, a much larger study involving more infants is needed.
It is planned that 2158 premature infants will be included in this study, who will be less than 48 hours old at the time they begin taking part. At the end of the study, the researchers will compare the infants who received IBP 9414 with those who received placebo, to help decide if receiving IBP 9414 can prevent NEC and if it is safe for premature infants.
While the study doctor responsible for your child will monitor the safety of your individual infant, the safety of all infants in the study, as well as the effect of IBP 9414, will also be monitored on an ongoing basis throughout the study by a so-called Data Monitoring Committee (DMC). A DMC is a panel of experts who are independent from the study team and the pharmaceutical company developing IBP 9414.
Most of the infants (1942) in the study will weigh up to 1000 grams birth weight (about 2 lbs) and the rest (216) will weigh 1001 to 1500 grams (about 2 lbs to about 3 lbs).
The study will start with a group of 300 infants, all of whom will be in the intermediate weight category (750-1000 grams category). After 300 infants have completed treatment, a panel of experts (called a Data Monitoring Committee or DMC), who know which treatment each infant received, will determine if IBP-9414 appears to be safe and well tolerated. Enrollment in the study will continue during this review.
Based on the DMC recommendation, enrollment will open to infants from the lower weight category (500 749 grams), alongside the intermediate weight category (750 1000 grams).
A second DMC safety review will occur after the first 600 infants have completed treatment. Enrollment in the study will continue during this review.
A third DMC safety review will be performed after 1400 infants have completed treatment. Enrollment in the study will continue during this review.
After 1400 infants, the plan is to open recruitment to infants in the higher birth weight category (1001 1500 grams). The study will continue with all 3 birth weight categories until 2158 infants have been enrolled
More information about research and clinical trials
The purpose of this study is to study environmental risk factors and epigenetic processes as potential contributors to neurodevelopmental impairments in a group of individuals at very high risk by focusing on the relationship of prenatal exposure to placental inflammation markers and neonatal inflammation markers, the relationship of these inflammation markers to functional neuodevelopmental disorders and on the relationship of these markers to brain structural abnormalities.
More information about research and clinical trials
