HyponatremiaPhase 4NCT04035564
Early Sodium Intake in Preterm Newborns
A Phase 4 study testing Sodium < 1mEq/kg/day and Sodium 5mEq/kg/day in people with Hyponatremia and Premature, run by Hospital del Niño "Dr. Federico Gomez Santos" at 1 site in Mexico.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 24 hours
- Conditions the study is for
- Hyponatremia, Premature
- What is being tested?
- Sodium < 1mEq/kg/day and Sodium 5mEq/kg/day
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMexico
- Study dates
- 30 Mar 2018to 20 Mar 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants <35 Weeks gestation
Who cannot join
- Urinary malformations
- Congenital abdominal wall defect
- Intestinal atresia / obstruction
- Congenital heart defect
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital del Niño Dr Federico Gomez Santos
Saltillo, Coahuila, 25280
About this study
Official title: Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Hyponatremia, Premature
- Being tested
- Sodium < 1mEq/kg/day, Sodium 5mEq/kg/day
- Keywords
- Preterm infant, Sodium, Hyponatremia
- Medical subject headings
- Hyponatremia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium < 1mEq/kg/dayDrug
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
Sodium 5mEq/kg/dayDrug
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
| Study group | Role | What they receive |
|---|---|---|
| Sodium < 1mEq/kg/day | Active comparator | Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one Receives: Drug: Sodium < 1mEq/kg/day |
| Sodium 5mEq/kg/day | Experimental | Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one Receives: Drug: Sodium 5mEq/kg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hyponatremia
serum sodium <130mEq/L
Measured: 72 hours
Hypernatremia
serum sodium >150mEq/L
Measured: 72 hours
Secondary outcomes (7)
% Weight Change
The difference between initial weight and 72hrs weight, expressed in percentage of birth weight.
Measured: Initial weight (baseline) vs 72 hours
Change in Serum Sodium
The difference between current serum sodium and initial serum sodium
Measured: Initial serum sodium (baseline) vs 72 hours
Weight Change
The difference between current weight and initial weight
Measured: Initial weight (baseline) vs 72 hours
Number of Participants With Late-onset Sepsis
Positive blood culture and/or 5 days of continuous antimicrobial therapy
Measured: 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
Measured: 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).
Measured: Patients will be followed during hospitalization, an expected average of 3 months of age
Mortality
Death during hospitalization.
Measured: Patients will be followed during hospitalization, an expected average of 3 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start30 Mar 2018
- Primary completion2 Mar 2020
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, csanchezg, Hospital del Niño "Dr. Federico Gomez Santos"
- Investigators
- Carlos Sanchez, MD, Principal investigator, Pediatric NephrologyBen D Valdes, MD, Principal investigator, Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04035564
- Sponsor's protocol ID
- 01/03/18N01
- Status last verified
- Apr 2020
- First submitted
- 23 Jul 2019
- Last updated
- 21 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24379232Bhatia 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.
PubMed 16625217Moritz 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.
PubMed 19858147Balasubramanian 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.
PubMed 22040311Al-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.
PubMed 6497431Gawlowski 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.
PubMed 17096711Lonnqvist 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.
PubMed 24368557Oh 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.
PubMed 23276435Hartnoll 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.
PubMed 10634836Hartnoll 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.
PubMed 10634837Lorenz 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.
PubMed 7050331Costarino 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.
PubMed 1731034Koletzko 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.
PubMed 16254497Bolisetty 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.
PubMed 24548745
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04035564
- Acronym / sponsor ID
- 01/03/18N01
- Conditions
- Hyponatremia, Premature
- Keywords
- Preterm infant, Sodium, Hyponatremia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hospital del Niño "Dr. Federico Gomez Santos"University, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 20 Mar 2020 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Posted 8 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium < 1mEq/kg/day | Active comparator | Drug: Sodium < 1mEq/kg/daySodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one |
| Sodium 5mEq/kg/day | Experimental | Drug: Sodium 5mEq/kg/daySodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one |
Who may qualify
- Ages
- Up to 24 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Preterm infants <35 Weeks gestation
Key exclusion criteria (4 listed)
- Urinary malformations
- Congenital abdominal wall defect
- Intestinal atresia / obstruction
- Congenital heart defect
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium < 1mEq/kg/daySodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1 | Drug | Sodium < 1mEq/kg/day |
| Sodium 5mEq/kg/daySodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1 | Drug | Sodium 5mEq/kg/day |
Primary outcome
Hyponatremia
Time frame: 72 hours
serum sodium <130mEq/L
Hypernatremia
Time frame: 72 hours
serum sodium >150mEq/L
7 secondary outcomes
% Weight Change
Time frame: Initial weight (baseline) vs 72 hours
Change in Serum Sodium
Time frame: Initial serum sodium (baseline) vs 72 hours
Weight Change
Time frame: Initial weight (baseline) vs 72 hours
Number of Participants With Late-onset Sepsis
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Number of Participants With Necrotizing Enterocolitis
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Number of Participants With Intraventricular Hemorrhage
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Mortality
Time frame: Patients will be followed during hospitalization, an expected average of 3 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24379232Wang 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.
- Background: PubMed 16625217Bhatia 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.
- Background: PubMed 19858147Moritz 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.
- Background: PubMed 22040311Balasubramanian 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.
- Background: PubMed 6497431Al-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.
- Background: PubMed 17096711Gawlowski 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.
- Background: PubMed 24368557Lonnqvist 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.
- Background: PubMed 23276435Oh 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.
- Background: PubMed 10634836Hartnoll 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.
- Background: PubMed 10634837Hartnoll 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.
- Background: PubMed 7050331Lorenz 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.
- Background: PubMed 1731034Costarino 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Sanchez, MD principal investigator
Pediatric Nephrology
Ben D Valdes, MD principal investigator
Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sodium < 1mEq/kg/day and Sodium 5mEq/kg/day in people with Hyponatremia and Premature, run by Hospital del Niño "Dr. Federico Gomez Santos" at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hyponatremia (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04035564, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.