Physiologic Approach to Sodium Supplementation in Premature Infants

NCT03889197 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 1902815407
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Postnatal Growth Disorder; Growth and development

Outcome Measures

Primary Outcomes (3)

• Change in Somatic Growth (Weight)

  Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant weight is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.

  between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).

• Change in Somatic Growth (Length)

  Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant length is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.

  between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).

• Change in Somatic Growth (Head Circumference)

  Evaluated by the change in Z-score (standard score) provides a measure of how many standard deviations above or below the population mean the infant head circumference is. A Z-score of 0 represents the population mean. A positive z-score would indicate better growth.

  between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).

Secondary Outcomes (11)

• Change in Somatic Growth (Weight) at Discharge/Transfer

  between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).

• Change in Somatic Growth (Weight) at Discharge/Transfer

  between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).

• Change in Somatic Growth (Length) at Discharge/Transfer

  between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

• Change in Somatic Growth (Head Circumference) at Discharge/Transfer

  between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

• Received Diuretic Therapy

  between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

Study Arms (2)

Control

NO INTERVENTION

Standard of care sodium supplementation as directed by the medical care team

Sodium supplementation algorithm

ACTIVE COMPARATOR

Beginning on the 14th -16th postnatal day and continuing until 36 weeks postmenstrual age, infants randomized to the algorithm will have a spot urine sodium concentration determined every two weeks and sodium supplementation provided according to the algorithm.

Drug: Sodium supplementation guided by urine sodium concentration algorithm

Interventions

Sodium supplementation guided by urine sodium concentration algorithm DRUG

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.

Sodium supplementation algorithm

Eligibility Criteria

• Age: 7 Days - 16 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Indiana University: lead
• Thrasher Research Fund: collaborator

Study Sites (3)

Indiana University Health North

Carmel, Indiana, 46032, United States

Location

Riley Hospital for Children at IU Health

Indianapolis, Indiana, 46202, United States

Location

Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, 46202, United States

Location

Related 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.

  PMID: 29486497 BACKGROUND

Results Point of Contact

• Title: Kelly Mosesso, MA; Biostatistician II
• Organization: Department of Biostatistics and Health Data Science, Indiana University School of Medicine

kmosesso@iu.edu

317-278-5439

Study Officials

• Gregory M Sokol, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Jeffrey L Segar, MD

  Medical College Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data entered as group A and B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: July 1, 2019
• Primary Completion: July 22, 2023
• Study Completion: August 15, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)