Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants (PAS)

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.

Study Overview

• Status: Completed
• Conditions: Low Birth Weight
• Intervention / Treatment: Dietary supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis); Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48236
      • St. John Hospital & Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63104-1095
      • Cardinal Glennon Children's Hospital
  • Vermont
    • Burlington, Vermont, United States, 05401
      • VT Children's at Fletcher-Allen Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Placebo; routine feedings

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vermont Oxford Network
• Collaborators: University of Vermont; St. Louis University; Cardinal Glennon Children's Hospital; Saint John Hospital & Medical Center
• Investigators: Principal Investigator: Mohamad Al-Hosni, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: July 14, 2010
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (Estimate): July 16, 2010

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: nutrition; probiotics; growth; premature infants; extremely low birth weight; growth in extremely low birth weight infants
• Additional Relevant MeSH Terms: Body Weight; Birth Weight
• Other Study ID Numbers: CHRMS 08-019