Clinical trial NCT01164124: Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
Official title: Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Birth Weight
Keywords: extremely low birth weight
probiotics
growth
nutrition
premature infants
growth in extremely low birth weight infants
Lead sponsor: Vermont Oxford Network
Sponsor class: NETWORK
Collaborators: name: University of Vermont
name: St. Louis University
name: Cardinal Glennon Children's Hospital
name: Saint John Hospital & Medical Center
First posted: 2010-07-16
Enrollment: 101
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Growth
timeFrame: 34 weeks postmenstrual age
measure: Growth
timeFrame: 28 days from study entry
measure: Feeding Tolerance
timeFrame: 28 days from study entry
Secondary outcomes:
measure: Antimicrobial therapy
timeFrame: 34 weeks post menstrual age
measure: Complications of prematurity
timeFrame: until hospital discharge
Other outcomes:
Locations:
city: Detroit
country: United States
facility: St. John Hospital & Medical Center
state: Michigan
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Hospital
state: Missouri
city: Burlington
country: United States
facility: VT Children's at Fletcher-Allen Health Care
state: Vermont
Study officials:
affiliation: St. Louis University
name: Mohamad Al-Hosni, MD
role: PRINCIPAL_INVESTIGATOR
References: