Physiologic Approach to Sodium Supplementation in Premature Infants

Postnatal Growth Disorder Clinical Trial

— Salt to Grow  

Official title:

Physiologic Approach to Sodium Supplementation in Premature Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889197
• Other study ID #: 1902815407
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2019
• Est. completion date: August 15, 2023

Study information

• Verified date: September 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Postnatal growth failure is a significant morbidity in very low birth weight (VLBW, <1500 grams at birth) infants. Efforts to promote growth and optimize nutritional support have included earlier initiation of parenteral nutrition and increased caloric and protein administration. While these advances in nutritional practices have resulted in improved growth, up to 50% of VLBW infants continue to experience postnatal growth failure (defined as discharge weight <10th percentile by Fenton growth charts) and over 25% experience severe postnatal growth failure (<3rd percentile). Current nutritional recommendations for sodium provision to preterm infants is 3-5 mEq/kg/d and fails to take into account the degree of renal immaturity present in extremely preterm infants. The investigators hypothesize that the sodium supplementation algorithm will improve in-hospital somatic growth (weight, length, and head circumference) between 2 weeks of postnatal age and 36 weeks postmenstrual age over current sodium replacement practices. The algorithm will be evaluated in a prospective, pragmatic, randomized trial. Infants in the sodium supplementation algorithm group will have a spot urine sodium concentration determined every two weeks beginning on the 14th postnatal day and continuing until 36 weeks postmenstrual age with sodium supplementation provided according to the algorithm.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 15, 2023
• Est. primary completion date: July 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Days to 16 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth Disorders
• Postnatal Growth Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

References & Publications (1)

Segar DE, Segar EK, Harshman LA, Dagle JM, Carlson SJ, Segar JL. Physiological Approach to Sodium Supplementation in Preterm Infants. Am J Perinatol. 2018 Aug;35(10):994-1000. doi: 10.1055/s-0038-1632366. Epub 2018 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in somatic growth (weight)	evaluated by the change in Z-score	between 2 weeks of age and 36 weeks conceptual age
Primary	Change in somatic growth (length)	evaluated by the change in Z-score	between 2 weeks of age and 36 weeks conceptual age
Primary	Change in somatic growth (head circumference)	evaluated by the change in Z-score	between 2 weeks of age and 36 weeks conceptual age
Secondary	Change in somatic growth (weight)	evaluated by the change in Z-score	between 2 weeks of age and discharge or transfer from the NICU or 44 weeks corrected age (whichever occurs first)
Secondary	Change in somatic growth (length)	evaluated by the change in Z-score	between 2 weeks of age and discharge or transfer from the NICU or 44 weeks corrected age (whichever occurs first)
Secondary	Change in somatic growth (head circumference)	evaluated by the change in Z-score	between 2 weeks of age and discharge or transfer from the NICU or 44 weeks corrected age (whichever occurs first)
Secondary	Total body water	Measured by the doubly labeled water method	32 weeks conceptual age
Secondary	Energy expenditure	Measured by the doubly labeled water method	32 weeks conceptual age
Secondary	Incidence and severity of bronchopulmonary dysplasia (BPD)	as defined by the 2000 NICHD Workshop on BPD	36 weeks conceptual age
Secondary	Duration of mechanical ventilation	days on assisted ventilation	36 weeks conceptual age
Secondary	Need for supplemental oxygen	days on oxygen supplementation	36 weeks conceptual age
Secondary	Use of diuretic therapy	frequency of use	36 weeks conceptual age
Secondary	Retinopathy of prematurity	worst grade	36 weeks conceptual age