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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
90
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Change in Somatic Growth (Weight) at Discharge/Transfer
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.
Time frame: 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
evaluated by the change in kilograms
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Time frame: 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
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.
Time frame: 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
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.
Time frame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Received Diuretic Therapy
number of participants who 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)
Duration of Mechanical Ventilation
days on assisted ventilation
Time frame: from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Need for Supplemental Oxygen at Discharge
supplemental oxygen requirement
Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
Jenson definition of bronchopulmonary dysplasia (BPD), rated 0 - 3; with 0 being no BPD and higher numbers being more severe disease
Time frame: determined at 36 weeks post-menstrual age
Retinopathy of Prematurity ≥ Stage 3
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.
Time frame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
Total Body Water
Calculated by the doubly labeled water method in ml/kg
Time frame: determined during participants 32nd post-menstrual week of life
Energy Expenditure
Calculated using the doubly labeled water method
Time frame: determined during the participants 32nd post-menstrual week of life