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Recruiting Observational

Chloride Imbalance in Preterm Infants

NCT06940856 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-05-15
Last updated
2026-08-06

Condition(s) studied

Bronchopulmonary Dysplasia (BPD)Mortality PredictionChloride Disorder

Investigational drug(s) / intervention(s)

Incomplete responseComplete responseBad response

Incomplete 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

Complete 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

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

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.

Eligibility

Sex
ALL
Min age
1 Hour
Max age
6 Weeks
Healthy volunteers
No
Inclusion Criteria: * Infants born \<32 weeks PMA or \<1500 grams * Infants admitted to NICU within the first 24 hours 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

Primary outcome measure(s)

  • BPD — From enrollment to the end of 36 weeks PMA
    BPD at 36 weeks PMA

Trial sites (1)

FacilityCityRegionStatus
Kanuni Sultan Suleyman Education and Research Hospital Istanbul Turkey Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940856 on ClinicalTrials.gov ↗ ← All trials in Turkey