The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants

October 9, 2018 updated by: Mercy Health System
This is a research study that will look at the effects of giving two nutritional supplements on extremely low birth infants (infants weighing less than 1000 grams or weighing less than approximately 2 lbs 3 1/2 ounces at birth). The nutritional supplements that will be studied are Culturelle for Kids/Culturelle Kids and Align. They are nutritional supplements that each contain a different probiotic. In this study the investigators will mainly be looking at the effect that these supplements may have on how well babies tolerate their feedings and how long they require supplemental intravenous fluids for nutritional support. The investigators will also, however, look at many other factors such as rate of growth, rates of infection, survival rate and the length of time the infant needs to be in the hospital. The investigators will also look at its effect on conditions/complications of prematurity such as bronchopulmonary dysplasia and chronic lung disease (chronic diseases of the lung associated with prematurity), necrotizing enterocolitis and intestinal perforations (serious diseases of the infant's intestines), retinopathy of prematurity (eye disease associated with prematurity), intracranial hemorrhage (bleeding into the brain) and patent ductus arteriosus (a blood vessel connecting two main blood vessels coming out of the heart that does not close spontaneously (by itself).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this research study is to investigate the effect of the administration of the nutritional supplements, Culturelle for Kids/Kids Culturelle in combination with Align, containing the Probiotics Lactobacillus GG and Bifidobacterium Infantis, on feeding tolerance (as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings) in high risk extremely low birth weight infants.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Rockford, Illinois, United States, 61103
        • Rockford Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Birthweight between 500-999 grams
  • Apgar score greater than or equal to 3 at 5 minutes
  • Infant free from any known major congenital anomalies or chromosomal/genetic anomalies
  • Infant without any known cyanotic or complex congenital heart disease
  • Infant NPO or on trophic enteral feedings than have been started less than 24 hours previously
  • Infant without prior history of necrotizing enterocolitis or gastrointestinal perforation
  • Infant without previous exposure to probiotics
  • Infant that will be ready to start trophic feedings within the first 14 days of life
  • Infant less than or equal to 14 days of age
  • Infant born to HIV negative mother
  • Written informed consent obtained from mother

Exclusion Criteria:

  • Infant born to HIV positive mother
  • Infant with history of prior probiotic exposure
  • Infant greater than 14 days of age
  • Infant on enteral feedings for greater than 24 hours
  • Infant with major congenital anomaly/chromosomal or genetic anomaly
  • Infant with cyanotic/complex congenital heart disease
  • Infant with previous gastrointestinal perforation/necrotizing enterocolitis
  • 5 minute Apgar score < 3

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Supplemented Group
500,000,0000 cells of Lactobacillus GG (utilizing either Culturelle for Kids or Kids Culturelle preparation) and 500,000,000 cells of Bifidobacterium Infantis (utilizing Align capsule) diluted in 3 ml breastmilk/formula and administered enterally from first day of enteral feeds until term gestation/discharge/transfer/death (whichever occurs first) every day infant is receives enteral feedings
Dietary supplement: Probiotic Supplemented Group
Other Names:
  • Align
  • Culture for Kids
  • Kids Culturelle
  • Lactobacillus GG
  • Bifidobacter Infantis
Sham Comparator: Control Group
3 ml enteral feeding of breastmilk/formula administered once daily in addition to regularly prescribed enteral feedings from day of first feeding until term gestation/discharge/transfer/death (which ever occurs first) and administered every day that infant receives enteral feedings
Dietary supplement: Control Group
Other Names:
  • Formula
  • Breastmilk

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feeding Tolerance
Time Frame: Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age
Feeding Tolerance as determined by the number of days infant is without enteral feedings due to feeding intolerance, number of days infant requires supplemental hyperalimentation/intravenous fluids for nutritional support and number of days to achieve full enteral feedings
Evaluated on a daily basis until hospital discharge/transfer/death up until one year of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Necrotizing Enterocolitis (Bell's Stage 2 or greater)
Time Frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until 1 year of age
Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until 1 year of age
Culture proven sepsis without Necrotizing Enterocolitis
Time Frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Chronic Lung Disease
Time Frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Periventricular Leukomalacia
Time Frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Mortality
Time Frame: Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Infant's entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Intraventricular Hemorrhage
Time Frame: Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Infants entire inpatient record assessed at/after time of hospital discharge/transfer/death up until one year of age
Daily weight gain in grams
Time Frame: Measured daily until time of hospital discharge/transfer/death up until one year of age
Measured daily until time of hospital discharge/transfer/death up until one year of age
Discharge weight measured and expressed by percentile of growth for age
Time Frame: Assessed at the time of discharge/transfer/death up until one year of age
Assessed at the time of discharge/transfer/death up until one year of age
Length of Stay
Time Frame: Measured at time of discharge/transfer/death up until one year of age
Measured at time of discharge/transfer/death up until one year of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mercy Health System

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rockford Memorial Hospital Development Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kim M Schmidt, MS, APN, NNP, Mercy Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • pROBIOTICS11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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