Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

The overall purpose of this research is to test whether adding a supplement to the feeding of
extremely low birth weight infant (infants weighing less than 2 pound 2 oz at birth) will
help him/her achieve full feeding faster and achieve better weight gain. The study also will
evaluate the benefit of that feeding supplement in decreasing the rate of infection (in the
blood or in the urine) and antibiotics use in those infants.

When babies are born, the digestive system (the gastrointestinal tract) is sterile. There are
no bacteria residing in their gut. When babies start feeding, it is normal for the intestine
to start growing several types of bacteria. These normal (good) bacteria are thought to be
helpful in keeping the intestine healthy. This is not the case in premature infants. It takes
premature infants a longer time to grow bacteria in their intestines and they have fewer
numbers of bacteria. In addition, the bacteria premature infants grow are not the normal one
that we see in healthy infants. Instead they grow unhealthy (bad) bacteria that can
potentially play a role in causing infection in the blood and urine.

Adding the normal (good) bacteria to the breast milk or infant formula might help to protect
premature babies from developing blood or urine infection. In addition, adding the good
bacteria might be beneficial in terms of better tolerance to milk feeding. As a result,
babies may have less episodes of feeding holding and have better weight gain. Two species of
bacteria, called Lactobacillus and Bifidobacteria, have been used to study this in other
studies of premature babies. These two species are the most plentiful bacteria seen in the
bowels of full term babies.

Participation in the study involves enrolling premature babies to receive supplement to the
feeding when he/she ready to feed. Babies will be randomly assigned to receive either a
bacteria (probiotic) supplement or be fed without supplement. The supplement will be added to
one feeding each day. Enrolled babies will continue to get the supplement for 6-10 week.
Other than the feeding supplement, being in this study will not affect care.

The main outcomes of the study will be feeding tolerance and growth. Other complications
associated with prematurity, on particular infection of either the gastrointestinal tract or
the blood stream will be evaluated.

Inclusion Criteria:

- birth weight less than or equal to 1000 grams,

- appropriately grown for gestational age,

- age 1 to 14 days inclusive,

- intention to start enteral feeds,

- written informed consent obtained

Exclusion Criteria:

- known life-threatening congenital anomaly or condition affecting

- gastrointestinal function,

- previous NEC or gastrointestinal perforation,

- previous supplementation with probiotics

- previous enteral feedings