Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
Condition: Low Birth Weight
MeSH terms: Body Weight; Birth Weight
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The probiotic regimen consisted of 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter & Gamble.Inc); routine feedings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: extremely low birth weight; probiotics; growth; nutrition; premature infants; growth in extremely low birth weight infants