Physiologic Approach to Sodium Supplementation in Premature Infants

Phase 4

Completed

• Conditions: Postnatal Growth Disorder
• Interventions: Drug: Sodium supplementation guided by urine sodium concentration algorithm

• Registration Number: NCT03889197
• Lead Sponsor: Indiana University

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-03-18
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-26
• Study Start: 2019-07-01
• Primary Completion: 2023-07-22
• Study Completion: 2023-08-15
• Results First Submitted: 2024-07-30
• Status Verified: 2024-08
• Results First Submitted QC: 2024-10-29
• Last Update Submitted: 2024-10-29
• Results First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium supplementation algorithm	Sodium supplementation guided by urine sodium concentration algorithm	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.

Primary Outcome Measures

Name	Time	Method
Change in Somatic Growth (Weight)	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.
Change in Somatic Growth (Length)	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.
Change in Somatic Growth (Head Circumference)	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 Outcome Measures

Name	Time	Method
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).	evaluated by the change in kilograms
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)	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.
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)	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.
Received Diuretic Therapy	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
Duration of Mechanical Ventilation	from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)	days on assisted ventilation
Need for Supplemental Oxygen at Discharge	assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)	supplemental oxygen requirement
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)	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
Retinopathy of Prematurity ≥ Stage 3	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.
Total Body Water	determined during participants 32nd post-menstrual week of life	Calculated by the doubly labeled water method in ml/kg
Energy Expenditure	determined during the participants 32nd post-menstrual week of life	Calculated using the doubly labeled water method

Trial Locations

Locations (3)

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, United States