Physiologic Approach to Sodium Supplementation in Premature Infants
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/29/2019 |
| Start Date: | May 2019 |
| End Date: | February 2022 |
| Contact: | Gregory M Sokol, MD |
| Email: | gsokol@iu.edu |
| Phone: | (317) 274-8468 |
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.
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.
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.
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. < 14 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
any 2 consecutive measurements) after the first week of life
5. Diuretic use near time of enrollment
6. Infant with an ostomy (infants receiving an ostomy after study entry will be
withdrawn)
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