Probiotics-Supplemented Feeding in Extremely Low Birth Weight Infants

NCT01164124 | Completed Phase 2 DMC

• 1 other identifier: CHRMS 08-019
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Birth Weight

Keywords

extremely low birth weight; probiotics; growth; nutrition; premature infants; growth in extremely low birth weight infants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Antimicrobial therapy

  34 weeks post menstrual age

• Complications of prematurity

  until hospital discharge

Study Arms (2)

Probiotic supplementation

EXPERIMENTAL

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)

Routine feedings

PLACEBO COMPARATOR

Other: Placebo

Interventions

Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis) 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)

Probiotic supplementation

Placebo OTHER

routine feedings

Routine feedings

Eligibility Criteria

• Age: 1 Day - 14 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• known life-threatening congenital anomaly or condition affecting
• gastrointestinal function,
• previous NEC or gastrointestinal perforation,
• previous supplementation with probiotics
• previous enteral feedings

Sponsors & Collaborators

• Vermont Oxford Network: lead
• University of Vermont: collaborator
• St. Louis University: collaborator
• Cardinal Glennon Children's Hospital: collaborator
• Saint John Hospital & Medical Center: collaborator

Study Sites (3)

St. John Hospital & Medical Center

Detroit, Michigan, 48236, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104-1095, United States

Location

VT Children's at Fletcher-Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Mohamad Al-Hosni, MD

  St. Louis University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 16, 2010
• Study Start: February 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 2, 2018

Record last verified: 2018-06

Locations

US (3)