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Physiologic Approach to Sodium Supplementation in Premature Infants

NCT03889197 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-11-22

Study results available
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Summary

Postnatal growth failure occurs in up to 50% of very low birth weight (VLBW, \<1500 grams at birth) infants as assessed by discharge weight. This study will evaluate if a sodium supplementation algorithm guided by spot urine sodium measurements can improve postnatal growth.

Conditions

  • Postnatal Growth Disorder

Interventions

DRUG

Sodium supplementation guided by urine sodium concentration algorithm

4 mEq/kg/d sodium added the first time urine \[Na\] below threshold; for each subsequent time urine \[Na\] below threshold, add additional 2 mEq/kg/d.

Sponsors & Collaborators

  • Thrasher Research Fund

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Gregory M Sokol, MD · Indiana University

  • Jeffrey L Segar, MD · Medical College Wisconsin

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Days
Max Age
16 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2023-07-22
Completion
2023-08-15
FDA Drug
Yes

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 NCT03889197 on ClinicalTrials.gov