- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780958
Retinol Status in Preterm Infants and Mothers
The Effect of Retinol and RBP Levels of Cord Blood and Mothers on Mortality and Morbidity in Prematures With 30 Weeks and Lower
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Population Babies born at this hospital with a gestational week of <30 were included in the study. Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent. A record was made of the gender and birth weight of the babies and gestation week, maternal age, gravidity, status of vitamin intake and use of vitamin A during pregnancy, and antenatal steroid administration in the mothers. A record was made of the presence of early membrane rupture (EMR) diagnosed during the present pregnancy of the mother, preeclampsia/eclampsia, pregnancy-induced hypertension, urinary infection, gestational diabetes mellitus and anemia, if present. We recorded also neonatal mortality and morbidity such as respiratory distress syndrome, retinopathy of prematurity, necrotizing enterocolitis, intraventricular hemorrhage, bronchopulmonary dysplasia,
Sampling and Test Study Method Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube, and centrifuged for 10 minutes at 4500 rpm after the completion of coagulation, and the sera were separated. Serum samples were frozen and stored at -80° until the analysis was performed. For the analysis, serum samples were thawed in appropriate circumstances and all analyzes were performed at the Medical Biochemistry Laboratory of Atatürk University at a single session.
In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA). The measurement range of the kit for retinol and RBP was 2ng/ml- 800 ng/ml and 0,07 - 100 ng/mL, respectively.
The formula "umbilical cord retinol/maternal retinol x100" was used for the calculation of placental retinol passage rate in order to show the percentage of maternal retinol passing to the umbilical cord .
Retinol deficiency was evaluated according to the WHO data. A level of < 20 µg/dl was accepted as a deficiency. The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey, 25100
- Ataturk University Medical Faculty
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Babies born l with a gestational week of <30 and their mothers were included in the study.
Exclusion Criteria:
- Patients were excluded in the presence of a major abnormality or known congenital metabolic disease in the mother or baby, and the presence of chronic liver, kidney or gastrointestinal system disease in the mother, or if the family did not give consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Study population
During the study period, babies born at this hospital with a gestational week of <30 were included .
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Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer.
Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube.In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retinol deficiency status in preterm infants and mothers
Time Frame: 4 months
|
Number of Participants with retinol deficiency was evaluated according to the WHO data.
Concentration of retinol level < 20 µg/dl was accepted as a deficiency.
The level of deficiency was accepted as < 200 ng/ml since the unit used in this present study was ng/ml.
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4 months
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Retinol deficiency in preterm infants with respiratory distress syndrome
Time Frame: 3 months
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Numbers of preterm infants with respiratory distress syndrome as assessed accordingly European Consensus Respiratory Distress Syndrome, and have been reported retinol deficiency according to WHO data .
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3 months
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Retinol deficiency in preterm infants with retinopathy of prematurity
Time Frame: 3 months
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Numbers of preterm infants with retinopathy of prematurity as assessed accordingly the International Classification of Retinopathy of Prematurity, and have been reported retinol deficiency according to WHO data .
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3 months
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Retinol deficiency in preterm infants with bronchopulmonary dysplasia
Time Frame: 3 months
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Numbers of preterm infants with bronchopulmonary dysplasia as assessed accordingly the 2001 National Institutes of Health (NIH) Workshop, and have been reported retinol deficiency according to WHO data .
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3 months
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Retinol deficiency in preterm infants with intraventricular hemorrhage
Time Frame: 3 months
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Numbers of preterm infants with intraventricular hemorrhage as assessed accordingly Grading System for Neonatal Intraventricular Hemorrhage, and have been reported retinol deficiency according to WHO data .
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3 months
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Mortality of preterm infants
Time Frame: 3 months
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It was planned to check mortality rate in preterm infants with retinol deficiency.
Retinol deficiency rate was calculated accordingly Who data.
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3 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Kadir Ş Tekgündüz, Assoc.Prof, Ataturk University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTU-2020-8630
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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