Newborn ComplicationNEOFLUIDNCT04781361
Comparison of the Isotonic and Hypotonic Intravenous Maintenance Fluids In Term Newborns: Neofluid Study
An observational study of Newborn Complication and Hyponatremia of Newborn, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Newborn Complication, Hyponatremia of Newborn, Hypernatremia of Newborn
- What is being tested?
- Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose and Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L
- Type of treatment
- Injection or infusion
- How many people
- 420 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2020to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 30 days
- All sexes
- Child
Study population: Hospitalized term newborns (>37 weeks) , requiring iv fluid treatment after 24 hour postnatal age
Who may be able to join
- Term newborns (>37 + 0/7 weeks) aged 24 hours to 30 days with a normal baseline serum sodium level between 135-145 mmol/L,with a treatment plan to include IV fluids at > 50% of maintenance
- Infants not received parenteral fluids in the last 24 hours before participation
- Infants receiving IV fluid administration at 50% to 100% of maintenance
Who cannot join
- Newborns with diagnoses that required specific fluid tonicity and volumes such as:
- Severe dehydration presenting with shock
- Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
- Renal insufficiency
- Adrenal insufficiency
- Diabetes mellitus and diabetes insipidus
Show all 14Show fewer
- Hypoxic ischemic encephalopathy
- Major congenital anomaly
- Patients receiving diuretic therapy
- Patients with obvious edema
- Heart or liver failure, portal hypertension with acid
- Pre-post operative patients
- Infants receiving total parenteral nutritional therapy
- Other: all conditions that require non-standard liquid content and quantities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study
Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia.
Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation.
Read more
The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic.
In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) < 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.
- Conditions
- Newborn Complication, Hyponatremia of Newborn, Hypernatremia of Newborn, Fluid Therapy, Sodium Chloride, Isotonic Dehydration
- Being tested
- Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose, Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L
- Keywords
- Newborn, fluid therapy, isotonic, hypotonic,NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextroseDrug
Also called B05BB02, 0.9% NaCl/Dextrose 5%
Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/LDrug
Also called B05BB02, 0.45% NaCl/5% dextrose, B05BB02, 0.33 % NaCl/5% dextrose, B05BB02, 0.20 % NaCl/5% dextrose
Hypotonic group will be given fluids containing lower than 130 mmol/L :
Dextrose 5% in 0.2% Sodium Chloride, or Dextrose 5% in 0.33 % Sodium Chloride,or Dextrose 5% in %0.45 Sodium Chloride, or Intravenous fluid containing Sodium Chloride < 130 mmol/L
| Study group | Role | What they receive |
|---|---|---|
| Isotonic fluid | Group, received isotonic maintenance fluid containing NaCl between 131 to 154 mmol/L such as:
* Dextrose 5% in 0.9% NaCl,
* Intravenous fluid containing NaCl between 131 to 154 mmol/L Receives: Drug: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose | |
| Hypotonic fluid | Group, received hypotonic maintenance fluid containing NaCl < 130 mmol/L such as:
* Dextrose 5 % in 0.02 % NaCl,
* Dextrose 5% in 0.033 % NaCl
* Dextrose 5% in 0.045 % NaCl
* Intravenous fluid containing NaCl < 130 mmol/L Receives: Drug: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean plasma Na
Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)
Measured: 24 hours after the intervention
Rate of development of hyponatremia
Plasma sodium (pNa) level <135 mmol/L
Measured: during the intervention
Rate of development of hypernatremia
Plasma sodium (pNa) level >145 mmol/L
Measured: during the intervention
Secondary outcomes (3)
Weight in kilograms
weight gain
Measured: during the intervention
length of stay
hospitalisation day
Measured: during the intervention
mortality
mortality due to complications of administered fluid
Measured: during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start30 Dec 2020
- Primary completion31 Dec 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Newborn ComplicationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Collaborators
- Izmir Katip Celebi University, Dr. Behcet Uz Children's Hospital, Eskisehir Osmangazi University, Necmettin Erbakan University, NCR International Hospital, Uşak University, Zekai Tahir Burak Women's Health Research and Education Hospital, Aydin Adnan Menderes University, Inonu University, Baskent University, Kecioren Education and Training Hospital, Istanbul University, Istanbul Medeniyet University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Kanuni Sultan Suleyman Training and Research Hospital, Medipol University, Cukurova University, Mersin Training and Research Hospital, Cigli Regional Training Hospital, Gulhane School of Medicine, Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital, Yuksek Ihtisas University, Ministry of Health University, Kayseri Regional Hospital, Suleyman Demirel University, Konya Private Medova Hospital, Ankara Yildirim Beyazıt University, Cumhuriyet University, Aydın Maternity and Children Hospital, Umraniye Education and Research Hospital, Selcuk University, Mersin University, Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Funda Tuzun, Dokuz Eylul University
- Investigators
- Hasan Ozkan, Prof., Principal investigator, Dokuz Eylül University- Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781361
- Sponsor's protocol ID
- 363-SBKAEK
- Acronym
- NEOFLUID
- Status last verified
- Jul 2023
- First submitted
- 4 Feb 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Clinical Guideline Centre. IV Fluids in Children: Intravenous Fluid Therapy in Children and Young People in Hospital. London: National Institute for Health and Care Excellence (UK); 2015 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK338141/
PubMed 26741016Balasubramanian 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 22040311McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.
PubMed 25519949Tuzun F, Akcura Y, Duman N, Ozkan H. Comparison of isotonic and hypotonic intravenous fluids in term newborns: is it time to quit hypotonic fluids. J Matern Fetal Neonatal Med. 2022 Jan;35(2):356-361. doi: 10.1080/14767058.2020.1718094. Epub 2020 Mar 29.
PubMed 32223482
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Isotonic and Hypotonic Intravenous Maintenance Fluids on Term Neonatal Babies Undergoing Intravenous Fluid Therapy: Multicenter Observational Neofluid Study
- ClinicalTrials.gov ID
- NCT04781361
- Acronym / sponsor ID
- NEOFLUID / 363-SBKAEK
- Conditions
- Newborn Complication, Hyponatremia of Newborn, Hypernatremia of Newborn, Fluid Therapy, Sodium Chloride, Isotonic Dehydration
- Keywords
- Newborn, fluid therapy, isotonic, hypotonic,NaCl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Collaborators
- Izmir Katip Celebi University, Dr. Behcet Uz Children's Hospital, Eskisehir Osmangazi University, Necmettin Erbakan University, NCR International Hospital, Uşak University, Zekai Tahir Burak Women's Health Research and Education Hospital, Aydin Adnan Menderes University, Inonu University, Baskent University, Kecioren Education and Training Hospital, Istanbul University, Istanbul Medeniyet University, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Kanuni Sultan Suleyman Training and Research Hospital, Medipol University, Cukurova University, Mersin Training and Research Hospital, Cigli Regional Training Hospital, Gulhane School of Medicine, Ministry of Health University, Bursa Yüksek İhtisas Training and Research Hospital, Yuksek Ihtisas University, Ministry of Health University, Kayseri Regional Hospital, Suleyman Demirel University, Konya Private Medova Hospital, Ankara Yildirim Beyazıt University, Cumhuriyet University, Aydın Maternity and Children Hospital, Umraniye Education and Research Hospital, Selcuk University, Mersin University, Istanbul University - Cerrahpasa
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Considering the physiological changes in fluid and electrolyte balance and providing proper support are one of the important aspects of neonatal intensive care. Maintenance intravenous fluids are designed to maintain homeostasis when a patient is unable to uptake required water, electrolytes, and energy. Hypotonic fluids are still the most commonly prescribed IV fluids for pediatric hospitalized patients. However, previous studies, including children older than one month of age revealed that traditionally used hypotonic fluids may lead to hyponatremia.
Because of the absence of evidence-based data, there is currently no clear consensus on the optimal composition of maintenance intravenous fluid therapy in newborns, leading to wide practice variation.
The National Clinical Guideline Center (NICE) 2015 recommends the use of isotonic fluids in term newborn infants and some newborn centers has begun to use isotonic fluids since guidelines recommendations. Since the publication of the NICE guideline, no studies have addressed this topic.
In this prospective, observational , multicentric study, conventional hypotonic fluids containing sodium chloride (NaCl) < 130 mmol/L compared with isotonic fluids (containing NaCl between 131-154 mmol/L) in terms of the risk of hyponatremia, hypernatremia, plasma sodium (pNa) level change, treatment morbidities, hospitalization duration and mortality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotonic fluid | – | Drug: Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextroseGroup, received isotonic maintenance fluid containing NaCl between 131 to 154 mmol/L such as: * Dextrose 5% in 0.9% NaCl, * Intravenous fluid containing NaCl between 131 to 154 mmol/L |
| Hypotonic fluid | – | Drug: Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/LGroup, received hypotonic maintenance fluid containing NaCl < 130 mmol/L such as: * Dextrose 5 % in 0.02 % NaCl, * Dextrose 5% in 0.033 % NaCl * Dextrose 5% in 0.045 % NaCl * Intravenous fluid containing NaCl < 130 mmol/L |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Age groups
- Child
- Study population
- Hospitalized term newborns (>37 weeks) , requiring iv fluid treatment after 24 hour postnatal age
Key inclusion criteria (3 listed)
- Term newborns (>37 + 0/7 weeks) aged 24 hours to 30 days with a normal baseline serum sodium level between 135-145 mmol/L,with a treatment plan to include IV fluids at > 50% of maintenance
- Infants not received parenteral fluids in the last 24 hours before participation
- Infants receiving IV fluid administration at 50% to 100% of maintenance
Key exclusion criteria (14 listed)
- Newborns with diagnoses that required specific fluid tonicity and volumes such as:
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 |
|---|---|---|
| Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextroseAlso: B05BB02, 0.9% NaCl/Dextrose 5%Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride | Drug | Isotonic fluid |
| Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/LAlso: B05BB02, 0.45% NaCl/5% dextrose, B05BB02, 0.33 % NaCl/5% dextrose, B05BB02, 0.20 % NaCl/5% dextroseHypotonic group will be given fluids containing lower than 130 mmol/L : Dextrose 5% in 0.2% Sodium Chloride, or Dextrose 5% in 0.33 % Sodium Chloride,or Dextrose 5% in %0.45 Sodium Chloride, or Intravenous fluid containing Sodium Chloride < 130 mmol/L | Drug | Hypotonic fluid |
Primary outcome
Change in mean plasma Na
Time frame: 24 hours after the intervention
Change in mean plasma sodium levels per hour (∆pNa mmol/L/hour)
Rate of development of hyponatremia
Time frame: during the intervention
Plasma sodium (pNa) level <135 mmol/L
Rate of development of hypernatremia
Time frame: during the intervention
Plasma sodium (pNa) level >145 mmol/L
3 secondary outcomes
Weight in kilograms
Time frame: during the intervention
length of stay
Time frame: during the intervention
mortality
Time frame: during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 26741016National Clinical Guideline Centre. IV Fluids in Children: Intravenous Fluid Therapy in Children and Young People in Hospital. London: National Institute for Health and Care Excellence (UK); 2015 Dec. Available from http://www.ncbi.nlm.nih.gov/books/NBK338141/
- 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 25519949McNab S, Ware RS, Neville KA, Choong K, Coulthard MG, Duke T, Davidson A, Dorofaeff T. Isotonic versus hypotonic solutions for maintenance intravenous fluid administration in children. Cochrane Database Syst Rev. 2014 Dec 18;2014(12):CD009457. doi: 10.1002/14651858.CD009457.pub2.
- Background: PubMed 32223482Tuzun F, Akcura Y, Duman N, Ozkan H. Comparison of isotonic and hypotonic intravenous fluids in term newborns: is it time to quit hypotonic fluids. J Matern Fetal Neonatal Med. 2022 Jan;35(2):356-361. doi: 10.1080/14767058.2020.1718094. Epub 2020 Mar 29.
- 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.
Hasan Ozkan, Prof. principal investigator
Dokuz Eylül University- Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newborn Complication and Hyponatremia of Newborn, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 3 inclusion and 14 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 27 Jul 2023. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in mean plasma Na (time frame: 24 hours after the intervention). The study lists 3 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 NCT04781361, which also lists 4 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 27 Jul 2023.