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The Effects of Probiotic Supplementation on Extremely Low Birthweight Infants

NCT01788761 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2018-10-11

No results posted yet for this study

Summary

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).

Conditions

  • Feeding Tolerance

Interventions

DIETARY_SUPPLEMENT

Probiotic Supplemented Group

DIETARY_SUPPLEMENT

Control Group

Sponsors & Collaborators

  • Rockford Memorial Hospital Development Foundation

    collaborator UNKNOWN

  • Mercy Health System

    lead NETWORK

Principal Investigators

  • Kim M Schmidt, MS, APN, NNP · Mercy Health System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2018-07-11
Completion
2018-07-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01788761 on ClinicalTrials.gov