Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Birth Weight

Intervention / Treatment
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* Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 14 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probiotic supplementation<br>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)<br>* 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)<br>|
| Placebo Comparator: Routine feedings<br> | Other: Placebo<br>* routine feedings<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antimicrobial therapy | Days of antimicrobial treatment until 34 weeks post menstrual age. | 34 weeks post menstrual age | 
| Complications of prematurity | common complications of prematurity including but not limited to sepsis, necrotizing enterocolitis, and mortality. | until hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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extremely low birth weight, probiotics, growth, nutrition, premature infants, growth in extremely low birth weight infants