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Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome. There is controversy about the time of initiation and the requirements of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.
This study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the Newborn Intensive Care Unit at Children Hospital in Saltillo Coahuila Mexico.
Infants receive at 24 hours of life; sodium (5mEq/kg/day) versus less than 1mEq/kg/day. Weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. Patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium < 1mEq/kg/day | Active Comparator | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one |
|
| Sodium 5mEq/kg/day | Experimental | Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium < 1mEq/kg/day | Drug | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hyponatremia | serum sodium <130mEq/L | 72 hours |
| Hypernatremia | serum sodium >150mEq/L | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| % Weight Change | The difference between initial weight and 72hrs weight, expressed in percentage of birth weight. | Initial weight (baseline) vs 72 hours |
| Change in Serum Sodium | The difference between current serum sodium and initial serum sodium |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Sanchez, MD | Pediatric Nephrology | Principal Investigator |
| Ben D Valdes, MD | Neonatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital del Niño Dr Federico Gomez Santos | Saltillo | Coahuila | 25280 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24379232 | Background | Wang J, Xu E, Xiao Y. Isotonic versus hypotonic maintenance IV fluids in hospitalized children: a meta-analysis. Pediatrics. 2014 Jan;133(1):105-13. doi: 10.1542/peds.2013-2041. Epub 2013 Dec 30. | |
| 16625217 | Background | Bhatia J. Fluid and electrolyte management in the very low birth weight neonate. J Perinatol. 2006 May;26 Suppl 1:S19-21. doi: 10.1038/sj.jp.7211466. |
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Recruitment period: March 30, 2018 - February 28, 2020
Inclusion Criteria:
Exclusion Criteria:
Location: Neonatology (Pediatric Hospital)
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium < 1mEq/kg/Day | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1 |
| FG001 | Sodium 5mEq/kg/Day | Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium < 1mEq/kg/Day | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1 |
| BG001 | Sodium 5mEq/kg/Day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational Age (Weeks) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hyponatremia | serum sodium <130mEq/L | Posted | Count of Participants | Participants | 72 hours |
|
Through hospitalization stay, an expected average of 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sodium < 1mEq/kg/Day | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one Sodium < 1mEq/kg/day: Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1 |
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Small numbers of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carlos Sanchez | Hospital del Niño de Saltillo "Dr. Federico Gomez Santos" | +528441757244 | sanchez.carlos8516@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2018 | Jan 23, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007010 | Hyponatremia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007752 | Obstetric Labor, Premature |
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| Sodium 5mEq/kg/day | Drug | Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1 |
|
| Initial serum sodium (baseline) vs 72 hours |
| Weight Change | The difference between current weight and initial weight | Initial weight (baseline) vs 72 hours |
| Number of Participants With Late-onset Sepsis | Positive blood culture and/or 5 days of continuous antimicrobial therapy | Patients will be followed during hospitalization, an expected average of 3 months of age |
| Number of Participants With Necrotizing Enterocolitis | Number of patients with Bell stage II or greater necrotizing enterocolitis Bell's Staging: Stage II A: Gastrointestinal signs: Increasing gastric aspirates, mild abdominal distention, fecal occult blood, absent bowel sounds. Systemic signs: Temperature instability, apnea, bradycardia, lethargy. Radiological findings: Intestinal dilatation, ileus, pneumatosis intestinalis. Stage II B: Gastrointestinal signs: As stage IIA plus abdominal tenderness. Systemic signs: As stage IIA plus metabolic acidosis and thrombocytopenia. Radiological findings: As stage IIA plus portal vein gas and ascites. Stage III A: Gastrointestinal signs: As stage IIB plus marked abdominal tenderness and generalised peritonitis. Systemic signs: As stage IIB plus hypotension and severe apnea. Radiological findings: As stage IIB Stage III B: Gastrointestinal signs: As stage IIIA As stage IIIA As stage IIIA plus pneumoperitoneum | Patients will be followed during hospitalization, an expected average of 3 months of age |
| Number of Participants With Intraventricular Hemorrhage | Bleeding into the brain´s ventricular system (intracranial ultrasound). | Patients will be followed during hospitalization, an expected average of 3 months of age |
| Mortality | Death during hospitalization. | Patients will be followed during hospitalization, an expected average of 3 months of age |
| 19858147 | Background | Moritz ML, Ayus JC. Hyponatremia in preterm neonates: not a benign condition. Pediatrics. 2009 Nov;124(5):e1014-6. doi: 10.1542/peds.2009-1869. Epub 2009 Oct 26. No abstract available. |
| 22040311 | Background | Balasubramanian K, Kumar P, Saini SS, Attri SV, Dutta S. Isotonic versus hypotonic fluid supplementation in term neonates with severe hyperbilirubinemia - a double-blind, randomized, controlled trial. Acta Paediatr. 2012 Mar;101(3):236-41. doi: 10.1111/j.1651-2227.2011.02508.x. Epub 2011 Nov 19. |
| 6497431 | Background | Al-Dahhan J, Haycock GB, Nichol B, Chantler C, Stimmler L. Sodium homeostasis in term and preterm neonates. III. Effect of salt supplementation. Arch Dis Child. 1984 Oct;59(10):945-50. doi: 10.1136/adc.59.10.945. |
| 17096711 | Background | Gawlowski Z, Aladangady N, Coen PG. Hypernatraemia in preterm infants born at less than 27 weeks gestation. J Paediatr Child Health. 2006 Dec;42(12):771-4. doi: 10.1111/j.1440-1754.2006.00975.x. |
| 24368557 | Background | Lonnqvist PA. III. Fluid management in association with neonatal surgery: even tiny guys need their salt. Br J Anaesth. 2014 Mar;112(3):404-6. doi: 10.1093/bja/aet436. Epub 2013 Dec 23. No abstract available. |
| 23276435 | Background | Oh W. Fluid and electrolyte management of very low birth weight infants. Pediatr Neonatol. 2012 Dec;53(6):329-33. doi: 10.1016/j.pedneo.2012.08.010. Epub 2012 Oct 12. |
| 10634836 | Background | Hartnoll G, Betremieux P, Modi N. Randomised controlled trial of postnatal sodium supplementation on oxygen dependency and body weight in 25-30 week gestational age infants. Arch Dis Child Fetal Neonatal Ed. 2000 Jan;82(1):F19-23. doi: 10.1136/fn.82.1.f19. |
| 10634837 | Background | Hartnoll G, Betremieux P, Modi N. Randomised controlled trial of postnatal sodium supplementation on body composition in 25 to 30 week gestational age infants. Arch Dis Child Fetal Neonatal Ed. 2000 Jan;82(1):F24-8. doi: 10.1136/fn.82.1.f24. |
| 7050331 | Background | Lorenz JM, Kleinman LI, Kotagal UR, Reller MD. Water balance in very low-birth-weight infants: relationship to water and sodium intake and effect on outcome. J Pediatr. 1982 Sep;101(3):423-32. doi: 10.1016/s0022-3476(82)80078-4. |
| 1731034 | Background | Costarino AT Jr, Gruskay JA, Corcoran L, Polin RA, Baumgart S. Sodium restriction versus daily maintenance replacement in very low birth weight premature neonates: a randomized, blind therapeutic trial. J Pediatr. 1992 Jan;120(1):99-106. doi: 10.1016/s0022-3476(05)80611-0. |
| 16254497 | Background | Koletzko B, Goulet O, Hunt J, Krohn K, Shamir R; Parenteral Nutrition Guidelines Working Group; European Society for Clinical Nutrition and Metabolism; European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN); European Society of Paediatric Research (ESPR). 1. Guidelines on Paediatric Parenteral Nutrition of the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) and the European Society for Clinical Nutrition and Metabolism (ESPEN), Supported by the European Society of Paediatric Research (ESPR). J Pediatr Gastroenterol Nutr. 2005 Nov;41 Suppl 2:S1-87. doi: 10.1097/01.mpg.0000181841.07090.f4. No abstract available. |
| 24548745 | Background | Bolisetty S, Osborn D, Sinn J, Lui K; Australasian Neonatal Parenteral Nutrition Consensus Group. Standardised neonatal parenteral nutrition formulations - an Australasian group consensus 2012. BMC Pediatr. 2014 Feb 18;14:48. doi: 10.1186/1471-2431-14-48. |
| Guardian declined consent |
|
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1 |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Birth weight | Mean | Standard Deviation | Grams |
|
| Length of hospital stay | Only patients who were discharged to home were included. | Mean | Standard Deviation | Days |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Hypernatremia | serum sodium >150mEq/L | Posted | Count of Participants | Participants | 72 hours |
|
|
|
|
| Secondary | % Weight Change | The difference between initial weight and 72hrs weight, expressed in percentage of birth weight. | Posted | Mean | Standard Deviation | % of birth weight | Initial weight (baseline) vs 72 hours |
|
|
|
|
| Secondary | Change in Serum Sodium | The difference between current serum sodium and initial serum sodium | Posted | Mean | Standard Deviation | mEq/L | Initial serum sodium (baseline) vs 72 hours |
|
|
|
|
| Secondary | Weight Change | The difference between current weight and initial weight | Posted | Mean | Standard Deviation | Grams | Initial weight (baseline) vs 72 hours |
|
|
|
|
| Secondary | Number of Participants With Late-onset Sepsis | Positive blood culture and/or 5 days of continuous antimicrobial therapy | Posted | Count of Participants | Participants | Patients will be followed during hospitalization, an expected average of 3 months of age |
|
|
|
|
| Secondary | Number of Participants With Necrotizing Enterocolitis | Number of patients with Bell stage II or greater necrotizing enterocolitis Bell's Staging: Stage II A: Gastrointestinal signs: Increasing gastric aspirates, mild abdominal distention, fecal occult blood, absent bowel sounds. Systemic signs: Temperature instability, apnea, bradycardia, lethargy. Radiological findings: Intestinal dilatation, ileus, pneumatosis intestinalis. Stage II B: Gastrointestinal signs: As stage IIA plus abdominal tenderness. Systemic signs: As stage IIA plus metabolic acidosis and thrombocytopenia. Radiological findings: As stage IIA plus portal vein gas and ascites. Stage III A: Gastrointestinal signs: As stage IIB plus marked abdominal tenderness and generalised peritonitis. Systemic signs: As stage IIB plus hypotension and severe apnea. Radiological findings: As stage IIB Stage III B: Gastrointestinal signs: As stage IIIA As stage IIIA As stage IIIA plus pneumoperitoneum | Posted | Count of Participants | Participants | Patients will be followed during hospitalization, an expected average of 3 months of age |
|
|
|
|
| Secondary | Number of Participants With Intraventricular Hemorrhage | Bleeding into the brain´s ventricular system (intracranial ultrasound). | Posted | Count of Participants | Participants | Patients will be followed during hospitalization, an expected average of 3 months of age |
|
|
|
|
| Secondary | Mortality | Death during hospitalization. | Posted | Count of Participants | Participants | Patients will be followed during hospitalization, an expected average of 3 months of age |
|
|
|
|
| 5 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Sodium 5mEq/kg/Day | Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one Sodium 5mEq/kg/day: Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1 | 2 | 19 | 0 | 19 | 0 | 19 |
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| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| Unknown or Not Reported |
|
| Mean Difference (Final Values) |
| -2.86 |
| Standard Error of the Mean |
| 1.286 |
| 2-Sided |
| 95 |
| -5.461 |
| -0.261 |
| Superiority |
| Mean Difference (Final Values) |
| -3.78 |
| Standard Error of the Mean |
| 2.299 |
| 2-Sided |
| 95 |
| -8.43 |
| 0.85 |
| Superiority |
| Mean Difference (Final Values) |
| -39.38 |
| Standard Error of the Mean |
| 17.22 |
| 2-Sided |
| 95 |
| -74.18 |
| -4.57 |
| Superiority |
| 0.62 |
| 2-Sided |
| Superiority |