Chloride Imbalance in Preterm Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-6
SponsorKanuni Sultan Suleyman Training and Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Infants born <32 weeks PMA or <1500 grams
Infants admitted to NICU within the first 24 hours
Disqualifiers
Infants with major congenital anomalies
Infants with chromosomal anomalies
Infants who have undergone enterostomy operation
Infants admitted to NICU after the first 24 hours
Trial 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.
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Incomplete response
Other interventionInfants 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
Other interventionInfants 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
Other interventionInfants died before 36 weeks PMA and infants diagnosed to have BPD at 36 weeks PMA
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Infants without dyschloremia3 interventions
Group B: Infants with dyschloremia3 interventions
Trial outcomes
Primary outcomes
1
BPD
BPD at 36 weeks PMA
Time frame
From enrollment to the end of 36 weeks PMASecondary outcomes
1
Mortality
Mortality within 36 weeks PMA
Time frame
From enrollment to the end of 36 weeks PMAOther 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 PMA2
PDA
Hemodynamically significant patent ductus arteriosus within 36 weeks PMA
Time frame
From enrollment to the end of 36 weeks PMA3
IVH
\>Grade 2 intraventricular hemorrhage within 36 weeks PMA
Time frame
From enrollment to the end of 36 weeks PMA4
ROP
Retinopathy of prematurity, ICROP classification stage \>2 at 36 weeks PMA
Time frame
From enrollment to the end of 36 weeks PMASponsors and contacts
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Source ClinicalTrials.gov