Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
Primary Purpose
Preterm Birth
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sodium algorithm
Sponsored by
About this trial
This is an interventional supportive care trial for Preterm Birth
Eligibility Criteria
Inclusion Criteria:
- Birthweight >500 grams and
- Gestational age at least 25 0/7weeks but less than 30 weeks.
- <14 days of age at time of randomization
Exclusion Criteria:
- Non-English speaking parents
- Major congenital anomalies
- grade underlying renal dysfunction (serum creatinine > 1.0 mg/dL or increase of >0.3 mg/DL between any two consecutive measurements)
- use of diuretics at the time initiation of intervention (approximately 14 days of age) But this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels
- any structural genitourinary criteria.
Sites / Locations
- Children's wisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Sodium algorithm
Control
Arm Description
Starting at 2 weeks of age, the sodium algorithm group will be started based on their sodium levels. This will be adjusted weekly based on weight gain and sodium levels.
Subjects will be cared for by current protocols
Outcomes
Primary Outcome Measures
Preterm infant weight gain
To determine the relationship among sodium intake, bodily growth and the gut in preterm infants
Secondary Outcome Measures
Microbiome
Microbiome diversity according to study group
Full Information
NCT ID
NCT05546814
First Posted
September 15, 2022
Last Updated
March 20, 2023
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT05546814
Brief Title
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
Official Title
Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome in Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2023 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status.
from this study will help us develop a better treatment for in the future.
Detailed Description
Premature infants are at an increased risk of postnatal growth failure and as well as developing short or long-term impaired neurodevelopment and cardio metabolic health.
For many years, it has been recognized that ideal growth is attainable with sufficient sodium intake and a positive sodium balance. The results of this study could have a significant impact on the care of preterm infants.
Infants will be randomized into one of two groups. One group will receive sodium supplementation as guided by a urine sodium concentration algorithm, one group will be managed by current standards. Randomization will occur at 2 weeks of postnatal age
Standard of care group Care for the participant will remain the same as if they were not in the study. Nutritional information, including sodium intake will be collected on three separate days weekly for 8 weeks. Stool samples will be collected for determining intestinal microbiome at 2 weeks, 5 weeks, 8 weeks and the day they are discharged from the hospital.
The study team will also collect detailed health information from participants hospital stay from the medical chart. Which will include gestational age, birth weight, sex, race ,ethnicity, mode of delivery and exposure to any steroids, antibiotics and clinical diagnoses.
Sodium supplementation group:
Participants will receive sodium supplementation per the urine sodium concentration algorithm. Urine sodium will be determined weekly, and if urine sodium concentration is below set value, dietary sodium supplementation is provided.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two cohorts; experimental and control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sodium algorithm
Arm Type
Experimental
Arm Description
Starting at 2 weeks of age, the sodium algorithm group will be started based on their sodium levels. This will be adjusted weekly based on weight gain and sodium levels.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects will be cared for by current protocols
Intervention Type
Procedure
Intervention Name(s)
Sodium algorithm
Intervention Description
Infants will receive sodium and follow a sodium supplementation schedule or algorithm. This means that based on the sodium levels collected from the samples (stool and urine) they will receive an increase or maintain the same amount to help
Primary Outcome Measure Information:
Title
Preterm infant weight gain
Description
To determine the relationship among sodium intake, bodily growth and the gut in preterm infants
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Microbiome
Description
Microbiome diversity according to study group
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
30 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Birthweight >500 grams and
Gestational age at least 25 0/7weeks but less than 30 weeks.
<14 days of age at time of randomization
Exclusion Criteria:
Non-English speaking parents
Major congenital anomalies
grade underlying renal dysfunction (serum creatinine > 1.0 mg/dL or increase of >0.3 mg/DL between any two consecutive measurements)
use of diuretics at the time initiation of intervention (approximately 14 days of age) But this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels
any structural genitourinary criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jeffrey Segar, MD
Phone
414-266-6820
Email
jsegar@mcw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Awe, BA
Phone
414-266-6560
Email
eawe@mcw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Segar, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Awe
Phone
414-266-6560
Email
eawe@mcw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome
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