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

This study has been completed.
Sponsor:
Collaborators:
University of Vermont
St. Louis University
Cardinal Glennon Children's Hospital
Saint John Hospital & Medical Center
Information provided by:
Vermont Oxford Network
ClinicalTrials.gov Identifier:
NCT01164124
First received: July 14, 2010
Last updated: July 15, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Low Birth Weight
Dietary Supplement: Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)
Other: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Vermont Oxford Network:

Primary Outcome Measures:
  • Growth [ Time Frame: 34 weeks postmenstrual age ] [ Designated as safety issue: No ]
    Percentage of infants with weight less than the 10th percentile at 34 weeks postmenstrual age.

  • Growth [ Time Frame: 28 days from study entry ] [ Designated as safety issue: No ]
    Average weight gain and growth velocity during the first 28 days from initiation of feeding.

  • Feeding Tolerance [ Time Frame: 28 days from study entry ] [ Designated as safety issue: No ]
    Volume of feeding per day during the first 28 days from the initiation of feeding.


Secondary Outcome Measures:
  • Antimicrobial therapy [ Time Frame: 34 weeks post menstrual age ] [ Designated as safety issue: No ]
    Days of antimicrobial treatment until 34 weeks post menstrual age.

  • Complications of prematurity [ Time Frame: until hospital discharge ] [ Designated as safety issue: Yes ]
    common complications of prematurity including but not limited to sepsis, necrotizing enterocolitis, and mortality.


Enrollment: 101
Study Start Date: February 2008
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164124

Locations
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
Sponsors and Collaborators
Vermont Oxford Network
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
  More Information

No publications provided

Responsible Party: Mohamad Al-Hosni, MD, Cardinal Glennon Children's Hospital
ClinicalTrials.gov Identifier: NCT01164124     History of Changes
Other Study ID Numbers: CHRMS 08-019
Study First Received: July 14, 2010
Last Updated: July 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vermont Oxford Network:
extremely low birth weight
probiotics
growth
nutrition
premature infants
growth in extremely low birth weight infants

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014