Chloride Imbalance in Preterm Infants

NCT06940856 | Not Yet Recruiting DMC

• 1 other identifier: Murat Kostu
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchopulmonary Dysplasia (BPD); Mortality Prediction; Chloride Disorder

Keywords

Bronchopulmonary dysplasia; Preterm infant; Mortality; Chloride imbalance

Outcome Measures

Primary Outcomes (1)

• BPD

  BPD at 36 weeks PMA

  From enrollment to the end of 36 weeks PMA

Secondary Outcomes (1)

• Mortality

  From enrollment to the end of 36 weeks PMA

Other Outcomes (6)

• NEC

  From enrollment to the end of 36 weeks PMA

• PDA

  From enrollment to the end of 36 weeks PMA

• IVH

  From enrollment to the end of 36 weeks PMA

Study Arms (2)

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

Incomplete response OTHER

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

Infants with dyschloremia; Infants without dyschloremia

Complete response OTHER

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

Infants with dyschloremia; Infants without dyschloremia

Bad response OTHER

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

Infants with dyschloremia; Infants without dyschloremia

Eligibility Criteria

• Age: 1 Hour - 6 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (1)

Kanuni Sultan Suleyman Education and Research Hospital

Istanbul, Turkey, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 2935779 BACKGROUND

• 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.

  PMID: 31727986 BACKGROUND

• 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.

  PMID: 3880419 BACKGROUND

• 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.

  PMID: 35734213 BACKGROUND

• 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.

  PMID: 33614850 BACKGROUND

• 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.

  PMID: 22505945 BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Interventions

YSH1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Murat Köstü

CONTACT

+905323932616; murat.kostu@saglik.gov.tr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 23, 2025
• Study Start: April 15, 2025
• Primary Completion: April 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

TU (1)