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Completed

NCT Number: NCT03889197

Physiologic Approach to Sodium Supplementation in Premature Infants

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.

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Key information

Conditions

Postnatal Growth Disorder

Age range

7 day–16 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Health North, Carmel, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • < 17 days of age at time of enrollment

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Change in Somatic Growth (Weight)

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

    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.

  2. Change in Somatic Growth (Length)

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

    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.

  3. Change in Somatic Growth (Head Circumference)

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

    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.

Secondary outcomes

  1. Change in Somatic Growth (Weight) at Discharge/Transfer

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

    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.

  2. Change in Somatic Growth (Weight) at Discharge/Transfer

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

    evaluated by the change in kilograms

  3. Change in Somatic Growth (Length) at Discharge/Transfer

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

    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.

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

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

    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.

  5. Received Diuretic Therapy

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

    number of participants who received diuretic therapy

  6. Duration of Mechanical Ventilation

    Time frame: from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

    days on assisted ventilation

  7. Need for Supplemental Oxygen at Discharge

    Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

    supplemental oxygen requirement

  8. Incidence and Severity of Bronchopulmonary Dysplasia (BPD)

    Time frame: determined at 36 weeks post-menstrual age

    Jenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease

  9. Retinopathy of Prematurity ≥ Stage 3

    Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)

    Number of participants with Retinopathy of prematurity ≥ Stage 3 as diagnosed by examination of an Ophthalmologist finding abnormal retinal blood vessel growth with ridge formation or retinal detachment.

  10. Total Body Water

    Time frame: determined during participants 32nd post-menstrual week of life

    Calculated by the doubly labeled water method in ml/kg

  11. Energy Expenditure

    Time frame: determined during the participants 32nd post-menstrual week of life

    Calculated using the doubly labeled water method

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Acronym: Salt to Grow

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Mar 26, 2019
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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