Physiologic Approach to Sodium Supplementation in Premature Infants

Completed · Phase 4

Conditions studied: Postnatal Growth Disorder

In brief

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.

Key facts

Study ID

NCT03889197

Run by

Indiana University

People needed

90

Starts

2019-07-01

Expected to finish

2023-08-15

Last updated by the study team

2024-11-22

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants with gestational age 25 0/7 - 29 6/7 at birth
• Birth weight ≥ 500 grams
• Admitted within the 1st week of life
• < 17 days of age at time of enrollment

You may not qualify if…

• Infants admitted after the 1st week of life
• Major congenital anomalies
• Structural genitourinary abnormality
• Renal dysfunction (serum creatinine > 1.0 mg/dl or an increase of ≥ 0.3 mg/dl between the 2 most recent consecutive measurements) immediately prior to the initiation of study procedures.
• Diuretic use less than 48 hours prior to initiation of study procedures
• Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)
• Infant with a diagnosis or suspicion of diabetes insipidus

Where it is running

• Indiana University Health North — Carmel, Indiana, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Sidney and Lois Eskenazi Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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