Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

NCT ID: NCT01164124

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-08-31

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.

Conditions

Low Birth Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Probiotic supplementation

500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter \& Gamble.Inc)

Group Type: EXPERIMENTAL

Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)

Intervention Type: DIETARY_SUPPLEMENT

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)

Routine feedings

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

routine feedings

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

routine feedings

Intervention Type: OTHER

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 14 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: collaborator

St. Louis University

OTHER

Sponsor Role: collaborator

Cardinal Glennon Children's Hospital

UNKNOWN

Sponsor Role: collaborator

Saint John Hospital & Medical Center

UNKNOWN

Sponsor Role: collaborator

Vermont Oxford Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamad Al-Hosni, MD

Role: PRINCIPAL_INVESTIGATOR

St. Louis University

Locations

St. John Hospital & Medical Center

Detroit, Michigan, United States

Cardinal Glennon Children's Hospital

St Louis, Missouri, United States

VT Children's at Fletcher-Allen Health Care

Burlington, Vermont, United States

Countries

United States

Other Identifiers

CHRMS 08-019

Identifier Type: -

Identifier Source: org_study_id