- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02024490
The Effect of Maternal and Neonatal Vitamin D Levels on Respiratory Distress Syndrome in Preterm Infants
6. januar 2014 opdateret af: Merih Cetinkaya, Kanuni Sultan Suleyman Training and Research Hospital
Respiratory distress syndrome (RDS) of the newborn, also called as hyaline membrane disease, is the most common cause of respiratory distress in premature infants, correlating with structural and functional lung immaturity.
The pathophysiology of RDS is complex.
Immature type II alveolar cells produce less surfactant that causes an increase in alveolar surface tension and a decrease in compliance.
This resultant atelectasis lead to pulmonary vascular constriction, hypoperfusion, and lung tissue ischemia.
RDS and prolonged ventilation and associated systemic/lung injury may also contribute to long term oxygen dependency and may result in bronchopulmonary dysplasia (BPD).
Vitamin D is a fat-soluble steroid hormone that primarily contributes to the maintenance of normal calcium homeostasis and skeletal mineralization.
In addition to its classical role in bone metabolism, vitamin D deficiency has been associated with impaired pulmonary function, increased incidence of viral and bacterial infections and inflammatory lung diseases.
Although exact mechanisms are not fully understood, vitamin D appears to impact on a variety of inflammatory and structural cells within the lung including macrophages, lymphocytes and epithelial cells.
To our best of knowledge, no study has evaluated the effect of vitamin D levels on the severity and presence of RDS in preterm infants.
Therefore, the aim of this study is to evaluate the possible role of maternal/neonatal vitamin D levels on RDS development in preterm infants.
We also aim to determine the possible association between maternal/neonatal vitamin D levels and the incidence of BPD and other neonatal morbidities.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Preterm infants with respiratory distress who are <37 weeks of gestational age and will be admitted to Neonatal Intensive Care Unit of Kanuni Sultan Suleyman Training and Research Hospital will be included in this prospective study.
Blood for neonatal and maternal vitamin D levels will be obtained from all infants and their mothers at the time of hospital admission.
The infants will be evaluated for RDS and surfactant requirement.
If they have RDS and need of mechanical ventilation, they will be intubated and given surfactant, if necessary.
The maternal and neonatal demographics of infants will be recorded.
Infants will also be followed up in terms of other morbidities including patent ductus arteriosus, necrotizing enterocolitis, retinopathy of prematurity, and especially BPD.
Then infants will be divided into three groups according to maternal/neonatal vitamin D levels (mild, moderate and severe vitamin D deficiency) and group comparisons will be performed Plasmas after separated and stored at -80 C. Levels of 25-OHD will be determined using Shimadzu LC-20AT model High Performance Liquid Chromatography (HPLC) system.
Data will be analyzed using SPSS software and appropriate statistical analyses will be performed.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Stanbul, Kalkun, 34052
- Kanuni Sultan Suleyman Training and Research Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
Ikke ældre end 3 dage (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Premature infants admitted to neonatal intesive care unit with the diagnosis of respiratory distress syndrome (RDS) will constitute the RDS group, whereas preterm infants without RDS will constitute the non-RDS group
Beskrivelse
Inclusion Criteria:
- Preterm infants <37 weeks of gestational age and are admitted to Neonatal Intensive Care Unit of Kanuni Sultan Suleyman Training and Research Hospital
- Preterm infants with clinical and laboratory findings of RDS
Exclusion Criteria:
- presence of maternal clinical and/or histological chorioamnionitis,
- presence of premature rupture of membranes (PROM),
- refusal of parental consent,
- lack of laboratory data,
- major congenital abnormalities
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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RDS group, non-RDS group
RDS group; infants with clinical, radiological and laboratory findings of RDS non-RDS group; infants without clinical, radiological and laboratory findings of RDS
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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development of respiratory distress in infants according to vitamin D levels
Tidsramme: 1 year
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A total of 100 preterm infants will be included and vitamin D levels will be compared between those with and without respiratory distress syndrome
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1 year
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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presence of vitamin D deficiency and bronchopulmonary dysplasia
Tidsramme: 1 year
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1 year
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Andre resultatmål
Resultatmål |
Tidsramme |
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development of prematurity morbidities
Tidsramme: 1year
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1year
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Merih Cetinkaya, MD, PhD, Kanuni Sultan Suleyman Training and Research Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Parekh D, Thickett DR, Turner AM. Vitamin D deficiency and acute lung injury. Inflamm Allergy Drug Targets. 2013 Aug;12(4):253-61. doi: 10.2174/18715281113129990049.
- Gupta A, Bush A, Hawrylowicz C, Saglani S. Vitamin D and asthma in children. Paediatr Respir Rev. 2012 Dec;13(4):236-43; quiz 243. doi: 10.1016/j.prrv.2011.07.003. Epub 2011 Sep 1.
- Bener A, Ehlayel MS, Tulic MK, Hamid Q. Vitamin D deficiency as a strong predictor of asthma in children. Int Arch Allergy Immunol. 2012;157(2):168-75. doi: 10.1159/000323941. Epub 2011 Oct 6.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. december 2012
Primær færdiggørelse (Faktiske)
1. december 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
27. december 2013
Først indsendt, der opfyldte QC-kriterier
30. december 2013
Først opslået (Skøn)
31. december 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
7. januar 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. januar 2014
Sidst verificeret
1. januar 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MC10001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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