Physiologic Approach to Sodium Supplementation in Premature Infants

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Thrasher Research Fund

Criteria

Inclusion Criteria:

1. Infants with gestational age 25 0/7 - 29 6/7 at birth

2. Birth weight ≥ 500 grams

3. Admitted within the 1st week of life

4. < 17 days of age at time of enrollment

Exclusion Criteria:

1. Infants admitted after the 1st week of life

2. Major congenital anomalies

3. Structural genitourinary abnormality

4. 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.

5. Diuretic use less than 48 hours prior to initiation of study procedures

6. Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)

7. Infant with a diagnosis or suspicion of diabetes insipidus