Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants (PAS)
|ClinicalTrials.gov Identifier: NCT01164124|
Recruitment Status : Completed
First Posted : July 16, 2010
Last Update Posted : July 16, 2010
|Condition or disease||Intervention/treatment||Phase|
|Low Birth Weight||Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) Other: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||August 2009|
Experimental: Probiotic supplementation
500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter & Gamble.Inc)
Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
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)
|Placebo Comparator: Routine feedings||
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164124
|United States, Michigan|
|St. John Hospital & Medical Center|
|Detroit, Michigan, United States, 48236|
|United States, Missouri|
|Cardinal Glennon Children's Hospital|
|St. Louis, Missouri, United States, 63104-1095|
|United States, Vermont|
|VT Children's at Fletcher-Allen Health Care|
|Burlington, Vermont, United States, 05401|
|Principal Investigator:||Mohamad Al-Hosni, MD||St. Louis University|