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RecruitingNCT06940856Updated Aug 6, 2026

Chloride Imbalance in Preterm Infants

An observational study in Bronchopulmonary Dysplasia (BPD), Mortality Prediction and Chloride Disorder, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 1 Hour to 6 Weeks. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

From the registry’s dates

  • Started May 2025; still recruiting 1 year 5 months later.

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Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
500
Ages
1 Hour to 6 Weeks
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 13 studies in Bronchopulmonary Dysplasia with a site in Turkey — 2 open to participants now, 2 under way, none of them phase 3. Bronchopulmonary Dysplasia · Turkey.

Started
2025
the only one that year
Observational
5 of 13
2 open now
Registered
11th of 13
by date
Lead sponsor
1 of 13
Kanuni Sultan Suleyman Training and Research Hospital

Among the 13 studies in Bronchopulmonary Dysplasia with a site in Turkey, this one is the only one that started in 2025, is one of 5 observational ones, and was the 11th registered.

Bronchopulmonary Dysplasia

362 studies on the registry are indexed under Bronchopulmonary Dysplasia; 85 are open to participants now.

Browse Bronchopulmonary Dysplasia studies →

Open to participants now

2 of the 13 studies in Bronchopulmonary Dysplasia with a site in Turkey are open now. Recruiting first, the newest first:

All 2 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 58 Bronchopulmonary Dysplasia studies recruiting now, 7 (12%) set no upper age limit and 50 (86%) stop at 75 or younger; 56 take children under 18; 11 take healthy volunteers.

This study: 1 Hour to 6 Weeks · all sexes · no healthy volunteers.

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02

Study summary

In adults and children low or high blood chloride levels are linked to the risk of death. The aim of this observational study is to determine whether there is a relationship between low or high blood chloride levels and the risk of death or long-term lung problems. We will also learn the risk factors and associated conditions of high or low blood chloride levels. We will include infants born before 32 weeks of pregnancy or have a birth weight of less than 1500 grams in the study. The main question it aims to answer is:

Is there a relationship between low or high blood chloride levels in the first 4-6 weeks of life and risk of death or long-term lung problems in premature babies? We will examine the medical reports of babies who were followed up in neonatal intensive care unit over the past 5 years.

Read the detailed description

Chloride balance usually parallels that of sodium, and it is strictly correlated to the extracellular volume balance. In addition plasma chloride and bicarbonate concentrations are inversely regulated through the chloride-bicarbonate exchange pump in renal collecting ducts, independent of sodium. Consequently, plasma chloride levels are closely correlated with pH (hypochloremia/metabolic alkalosis, hyperchloremia/metabolic acidosis).

In adults, dyschloremia is associated with mortality, acute kidney injury, and prolonged hospital stay. Hyperchloremia is often associated with severe sepsis. It has been shown that resuscitation with high-chloride fluids (eg: saline solution) instead of balanced fluids (e.g., Ringer's lactate) increases the need for inotropes in critically ill adults. Similarly, hyperchloremia in septic pediatric patients is linked to acute renal injury requiring dialysis, increased inotropic support, and mortality. In 1979, infants fed with chloride-deficient formula were reported to develop impaired head growth and neurologic sequelae.

Although serum chloride is routinely measured in neonatal intensive care units, its clinical significance is often overlooked. For this reason unlike sodium, literature on chloride metabolism in preterm infants is exceedingly limited.

Advancements in perinatal care over the past 50 years have significantly improved survival rates in preterm infants. However, a large proportion of very preterm infants who survive the neonatal period develop bronchopulmonary dysplasia (BPD). BPD, a chronic lung disease, manifests clinically through persistent respiratory support and/or oxygen dependency. Despite efforts to optimize neonatal care -such as controlled oxygen usage, non-invasive ventilation, volume-guarantee techniques, high-frequency ventilation, and caffeine therapy- BPD remains the most common complication among preterm infants and is associated with increased morbidity and mortality.

It has been suggested that extracellular volume expansion (edema) plays a role in the pathophysiology of BPD. Perlman et al.'s 1986 study demonstrated that infants who died from BPD exhibited hypochloremia, metabolic alkalosis, and complications like inadequate head growth, more frequently than those who survived. These findings highlight the critical importance of chloride imbalance in neonates, similar to findings in adult and pediatric populations.

This study aims to investigate the relationship between chloride balance and two major outcomes-mortality and the development of BPD-in preterm infants. Infants \<32 weeks postmentruel age (PMA) or weighing less than 1500 grams will be enrolled in the study. We also plan to explore the relationship of dyschloremia with other outcomes of prematurity (eg: patent ductus arteriosus, ventilator dependency, retinopathy of prematurity (ROP), necrotizing enterocolitis, intraventricular hemorrhage, periventricular leukomalacia, hospital stay. Lastly we plan to explore the risk factors and clinical/laboratory conditions that are associated with chloride level abnormalities.

If this study yields findings that underscore the clinical significance of chloride levels in preterm infants, similar to adults and children, then close monitoring of chloride balance and appropriate interventions could potentially reduce mortality and BPD incidence in preterm infants. Conversely, if results indicate that chloride balance lacks clinical significance in preterm infants, this will also contribute valuable information to the current literature.

03

Conditions studied

  • Bronchopulmonary Dysplasia (BPD)
  • Mortality Prediction
  • Chloride Disorder

Keywords

  • Bronchopulmonary dysplasia
  • Preterm infant
  • Mortality
  • Chloride imbalance
04

Who can participate

Ages eligible
1 Hour to 6 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population includes infants admitted to the Neonatal Intensive Care Unit at Kanuni Sultan Suleyman Training and Research Hospital over the past 5 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infants born \<32 weeks PMA or \<1500 grams
  • Infants admitted to NICU within the first 24 hours

Exclusion criteria

Exclusion Criteria:

  • Infants with major congenital anomalies
  • Infants with chromosomal anomalies
  • Infants who have undergone enterostomy operation
  • Infants admitted to NICU after the first 24 hours
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Infants without dyschloremia

    Infants with serum chloride levels within reference range before 36 weeks PMA

    Other: Incomplete response · Other: Complete response · Other: Bad response

  • Infants with dyschloremia

    Infants with serum chloride levels \<96 mEq/l and \>110 mEq/l before 36 weeks PMA

    Other: Incomplete response · Other: Complete response · Other: Bad response

Interventions

  • OtherIncomplete response

    Infants died before 36 weeks PMA, infants diagnosed to have BPD at 36 weeks PMA and infants developed major complications before 36 weeks PMA: 1. \>Stage 2 necrotizing enterocolitis according to Bell classification 2. Hemodynamically significant patent ductus arteriosus 3. \>Grade 2 intraventricular hemorrhage, 4. Retinopathy of prematurity, ICROP classification stage \>2 5. \>Stage 2 cystic periventricular leukomalacia 6. Ventricular dilatation/hydrocephalus requiring intervention

  • OtherComplete response

    Infants discharged before 36 weeks PMA and infants who reached 36 weeks PMA without BPD and major complications: 1. \>Stage 2 necrotizing enterocolitis according to Bell classification 2. Hemodynamically significant patent ductus arteriosus 3. \>Grade 2 intraventricular hemorrhage, 4. Retinopathy of prematurity, ICROP classification stage \>2 5. \>Stage 2 cystic periventricular leukomalacia 6. Ventricular dilatation/hydrocephalus requiring intervention

  • OtherBad response

    Infants died before 36 weeks PMA and infants diagnosed to have BPD at 36 weeks PMA

06

What researchers measure

Primary outcomes

  1. BPD

    BPD at 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

Secondary outcomes

  1. Mortality

    Mortality within 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

Other outcomes

  1. NEC

    \>Stage 2 necrotizing enterocolitis according to Bell classification within 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

  2. PDA

    Hemodynamically significant patent ductus arteriosus within 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

  3. IVH

    \>Grade 2 intraventricular hemorrhage within 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

  4. ROP

    Retinopathy of prematurity, ICROP classification stage \>2 at 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

  5. PVL

    \>Stage 2 cystic periventricular leukomalacia at 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

  6. Hydrocephalus

    Ventricular dilatation/hydrocephalus requiring intervention at 36 weeks PMA

    Time frame: From enrollment to the end of 36 weeks PMA

07

Study locations

1 of 1 sites recruiting
  • Kanuni Sultan Suleyman Education and Research Hospital
    Istanbul, Turkey, Turkey (Türkiye)
    Recruiting
    • Gokhan Buyukkale · Contactgbuyukkale@hotmail.com · +905057743497
    • Murat Köstü, MD · Contactmurat.kostu@saglik.gov.tr · +905323932616
    • Murat Köstü · Principal investigator
    • Halime Sema Can · Sub investigator
    • Tuncay Ozer · Sub investigator
    • Gokhan Buyukklae · Sub investigator
    • Gulsen Acar · Sub investigator
08

References and documents

Publications

  • Perlman JM, Moore V, Siegel MJ, Dawson J. Is chloride depletion an important contributing cause of death in infants with bronchopulmonary dysplasia? Pediatrics. 1986 Feb;77(2):212-6. PubMed 2935779 ↗
  • Thebaud B, Goss KN, Laughon M, Whitsett JA, Abman SH, Steinhorn RH, Aschner JL, Davis PG, McGrath-Morrow SA, Soll RF, Jobe AH. Bronchopulmonary dysplasia. Nat Rev Dis Primers. 2019 Nov 14;5(1):78. doi: 10.1038/s41572-019-0127-7. PubMed 31727986 ↗
  • Chutorian AM, LaScala CP, Ores CN, Nass R. Cerebral dysfunction following infantile dietary chloride deficiency. Pediatr Neurol. 1985 Nov-Dec;1(6):335-41. doi: 10.1016/0887-8994(85)90067-0. PubMed 3880419 ↗
  • Khan AH, Gai J, Faruque F, Bost JE, Patel AK, Pollack MM. Pediatric Mortality and Acute Kidney Injury Are Associated with Chloride Abnormalities in Intensive Care Units in the United States: A Multicenter Observational Study. J Pediatr Intensive Care. 2020 Nov 23;11(2):91-99. doi: 10.1055/s-0040-1719172. eCollection 2022 Jun. PubMed 35734213 ↗
  • Kalikkot Thekkeveedu R, Ramarao S, Dankhara N, Alur P. Hypochloremia Secondary to Diuretics in Preterm Infants: Should Clinicians Pay Close Attention? Glob Pediatr Health. 2021 Feb 4;8:2333794X21991014. doi: 10.1177/2333794X21991014. eCollection 2021. PubMed 33614850 ↗
  • Iacobelli S, Kermorvant-Duchemin E, Bonsante F, Lapillonne A, Gouyon JB. Chloride Balance in Preterm Infants during the First Week of Life. Int J Pediatr. 2012;2012:931597. doi: 10.1155/2012/931597. Epub 2012 Mar 8. PubMed 22505945 ↗

Individual participant data

Plan to share: Undecided — We are not sure that local ethics committee that approved our study will allow IPD sharing

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2025 (actual). Primary completion is estimated for Apr 2027, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 7, 2025
First posted
Apr 23, 2025
StartActual
May 15, 2025
Primary completionEst.
Apr 15, 2027
CompletionEst.
Dec 15, 2027
Last update
Aug 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06940856
Responsible party
Murat Köstü (Neonatologist, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Apr 23, 2025
Start date
May 15, 2025
Primary completion
Apr 15, 2027 (estimated)
Completion
Dec 15, 2027 (estimated)
Last update
Aug 6, 2026

Study contacts

Murat Köstü
Contact
murat.kostu@saglik.gov.tr
+905323932616

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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