Clinical Trial: Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Brief 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 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. 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 feedi
Sponsor: Vermont Oxford Network

Current Primary Outcome:

• Growth [ Time Frame: 34 weeks postmenstrual age ]
  Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.
• Growth [ Time Frame: 28 days from study entry ]
  Average weight gain and growth velocity during the first 28 days from initiation of feeding.
• Feeding Tolerance [ Time Frame: 28 days from study entry ]
  Volume of feeding per day during the first 28 days from the initiation of feeding.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Antimicrobial therapy [ Time Frame: 34 weeks post menstrual age ]
  Days of antimicrobial treatment until 34 weeks post menstrual age.
• Complications of prematurity [ Time Frame: until hospital discharge ]
  common complications of prematurity including but not limited to sepsis, necrotizing enterocolitis, and mortality.

Original Secondary Outcome: Same as current

Information By: Vermont Oxford Network

Dates:
Date Received: July 14, 2010
Date Started: February 2008
Date Completion:
Last Updated: July 15, 2010
Last Verified: July 2010