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Chloride Imbalance in Preterm Infants

NCT06940856 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-04-23

No results posted yet for this 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.

Conditions

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

Interventions

OTHER

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

OTHER

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

OTHER

Bad response

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

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Eligibility

Min Age
1 Hour
Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2026-04-15
Completion
2026-10-15

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06940856 on ClinicalTrials.gov