Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Low Birth Weight Clinical Trial

— PAS  

Official title:

Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01164124
• Other study ID #: CHRMS 08-019
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2008
• Est. completion date: August 2009

Study information

• Verified date: June 2018
• Source: Vermont Oxford Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Low Birth Weight

Intervention

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)

Other:
• Placebo
routine feedings

Locations

Country	Name	City	State
United States	VT Children's at Fletcher-Allen Health Care	Burlington	Vermont
United States	St. John Hospital & Medical Center	Detroit	Michigan
United States	Cardinal Glennon Children's Hospital	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Vermont Oxford Network	Cardinal Glennon Children's Hospital, Saint John Hospital & Medical Center, St. Louis University, University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth	Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.	34 weeks postmenstrual age
Primary	Growth	Average weight gain and growth velocity during the first 28 days from initiation of feeding.	28 days from study entry
Primary	Feeding Tolerance	Volume of feeding per day during the first 28 days from the initiation of feeding.	28 days from study entry
Secondary	Antimicrobial therapy	Days of antimicrobial treatment until 34 weeks post menstrual age.	34 weeks post menstrual age
Secondary	Complications of prematurity	common complications of prematurity including but not limited to sepsis, necrotizing enterocolitis, and mortality.	until hospital discharge