Clinical trial NCT03889197: Physiologic Approach to Sodium Supplementation in Premature Infants
Official title: Physiologic Approach to Sodium Supplementation in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postnatal Growth Disorder
Keywords: Postnatal Growth Disorder
Growth and development
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2019-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Change in Somatic Growth (Weight)
timeFrame: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
measure: Change in Somatic Growth (Length)
timeFrame: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
measure: Change in Somatic Growth (Head Circumference)
timeFrame: between 2 weeks of age and 36 weeks post-menstrual age or transfer from the NICU (whichever occurs first).
Secondary outcomes:
measure: Change in Somatic Growth (Weight) at Discharge/Transfer
timeFrame: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
measure: Change in Somatic Growth (Weight) at Discharge/Transfer
timeFrame: between 2 weeks of age and discharge/transfer from hospital, up to 44 weeks post-menstrual age (whichever occurs first).
measure: Change in Somatic Growth (Length) at Discharge/Transfer
timeFrame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Change in Somatic Growth (Head Circumference) at Discharge/Transfer
timeFrame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Received Diuretic Therapy
timeFrame: between 2 weeks of age and discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Duration of Mechanical Ventilation
timeFrame: from birth to discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Need for Supplemental Oxygen at Discharge
timeFrame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Incidence and Severity of Bronchopulmonary Dysplasia (BPD)
timeFrame: determined at 36 weeks post-menstrual age
measure: Retinopathy of Prematurity ≥ Stage 3
timeFrame: assessed at discharge/transfer from the NICU or 44 weeks post-menstrual age (whichever occurs first)
measure: Total Body Water
timeFrame: determined during participants 32nd post-menstrual week of life
measure: Energy Expenditure
timeFrame: determined during the participants 32nd post-menstrual week of life
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Indiana University Health North
state: Indiana
city: Indianapolis
country: United States
facility: Riley Hospital for Children at IU Health
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Gregory M Sokol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical College Wisconsin
name: Jeffrey L Segar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.