Phase 4
N=90
Physiologic Approach to Sodium Supplementation in Premature Infants
Postnatal Growth Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03889197 ↗Enrolled (actual)
90
Serious AEs
5.8%
Results posted
Nov 2024
Primary outcome: Primary: Change in Somatic Growth (Weight) — 0.04; 0.16 score on a scale — p=0.162
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sodium supplementation guided by urine sodium concentration algorithm (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Somatic Growth (Weight) |
0.04; 0.16 | 0.162 |
| PRIMARY Change in Somatic Growth (Length) |
-0.34; -0.48 | 0.242 |
| PRIMARY Change in Somatic Growth (Head Circumference) |
0.60; 0.54 | 0.956 |
| SECONDARY Change in Somatic Growth (Weight) at Discharge/Transfer |
2.00; 2.14 | 0.445 |
| SECONDARY Change in Somatic Growth (Weight) at Discharge/Transfer |
2.00; 2.14 | 0.445 |
| SECONDARY Change in Somatic Growth (Length) at Discharge/Transfer |
-0.39; 0.92 | 0.746 |
| SECONDARY Change in Somatic Growth (Head Circumference) at Discharge/Transfer |
1.03; 2.07 | 0.979 |
| SECONDARY Received Diuretic Therapy |
7; 11 | 0.289 |
| SECONDARY Duration of Mechanical Ventilation |
12.60; 8.74 | 0.940 |
| SECONDARY Need for Supplemental Oxygen at Discharge |
7; 13 | 0.126 |
| SECONDARY Incidence and Severity of Bronchopulmonary Dysplasia (BPD) |
16; 15; 11; 10; 12; 16 | 0.738 |
| SECONDARY Retinopathy of Prematurity ≥ Stage 3 |
4; 2 | 0.676 |
| SECONDARY Total Body Water |
755.5; 756.2 | 0.996 |
| SECONDARY Energy Expenditure |
61.6; 65.4 | 0.095 |
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.
Eligibility Criteria
Inclusion Criteria
- Infants with gestational age 25 0/7 - 29 6/7 at birth
- Birth weight ≥ 500 grams
- Admitted within the 1st week of life
- 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- Infant with an ostomy (infants receiving an ostomy after study entry will be withdrawn)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
Data sourced from ClinicalTrials.gov (NCT03889197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.