NCT04035564

Brief 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. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2018

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2020

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
19 days until next milestone

Results Posted

Study results publicly available

April 8, 2020

Completed
Last Updated

April 21, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

July 23, 2019

Results QC Date

March 25, 2020

Last Update Submit

April 20, 2020

Conditions

HyponatremiaPremature

Keywords

Preterm infantSodiumHyponatremia

Outcome Measures

Primary Outcomes (2)

  • Hyponatremia

    serum sodium \<130mEq/L

    72 hours

  • Hypernatremia

    serum sodium \>150mEq/L

    72 hours

Secondary Outcomes (7)

  • % Weight Change

    Initial weight (baseline) vs 72 hours

  • Change in Serum Sodium

    Initial serum sodium (baseline) vs 72 hours

  • Weight Change

    Initial weight (baseline) vs 72 hours

  • Number of Participants With Late-onset Sepsis

    Patients will be followed during hospitalization, an expected average of 3 months of age

  • Number of Participants With Necrotizing Enterocolitis

    Patients will be followed during hospitalization, an expected average of 3 months of age

  • +2 more secondary outcomes

Study Arms (2)

Sodium < 1mEq/kg/day

ACTIVE COMPARATOR

Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one

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

Drug: Sodium 5mEq/kg/day

Interventions

Sodium < 1mEq/kg/dayDRUG

Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1

Sodium < 1mEq/kg/day
Sodium 5mEq/kg/dayDRUG

Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1

Sodium 5mEq/kg/day

Eligibility Criteria

AgeUp to 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants \<35 Weeks gestation

You may not qualify if:

  • Urinary malformations
  • Congenital abdominal wall defect
  • Intestinal atresia / obstruction
  • Congenital heart defect

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital del Niño Dr Federico Gomez Santos

Saltillo, Coahuila, 25280, Mexico

Location

Related Publications (14)

  • 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.

    PMID: 24379232BACKGROUND

  • 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.

    PMID: 16625217BACKGROUND

  • 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.

    PMID: 19858147BACKGROUND

  • 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.

    PMID: 22040311BACKGROUND

  • 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.

    PMID: 6497431BACKGROUND

  • 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.

    PMID: 17096711BACKGROUND

  • 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.

    PMID: 24368557BACKGROUND

  • 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.

    PMID: 23276435BACKGROUND

  • 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.

    PMID: 10634836BACKGROUND

  • 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.

    PMID: 10634837BACKGROUND

  • 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.

    PMID: 7050331BACKGROUND

  • 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.

    PMID: 1731034BACKGROUND

  • 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.

    PMID: 16254497BACKGROUND

  • 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.

    PMID: 24548745BACKGROUND

MeSH Terms

Conditions

HyponatremiaPremature Birth

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Limitations and Caveats

Small numbers of subjects analyzed.

Results Point of Contact

Title
Carlos Sanchez
Organization
Hospital del Niño de Saltillo "Dr. Federico Gomez Santos"
sanchez.carlos8516@gmail.com
+528441757244

Study Officials

  • Carlos Sanchez, MD

    Pediatric Nephrology

    PRINCIPAL INVESTIGATOR

  • Ben D Valdes, MD

    Neonatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Nephrology

Study Record Dates

First Submitted

July 23, 2019

First Posted

July 29, 2019

Study Start

March 30, 2018

Primary Completion

March 2, 2020

Study Completion

March 20, 2020

Last Updated

April 21, 2020

Results First Posted

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)