Retinol Status in Preterm Infants and Mothers
Primary Purpose
Vitamin A Deficiency
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.
Sponsored by
About this trial
This is an interventional other trial for Vitamin A Deficiency focused on measuring Retinol, Preterm infant, Morbidity, Placenta
Eligibility Criteria
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.
Sites / Locations
- Ataturk University Medical Faculty
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Study population
Arm Description
During the study period, babies born at this hospital with a gestational week of <30 were included .
Outcomes
Primary Outcome Measures
Retinol deficiency status in preterm infants and mothers
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.
Retinol deficiency in preterm infants with respiratory distress syndrome
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 .
Retinol deficiency in preterm infants with retinopathy of prematurity
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 .
Retinol deficiency in preterm infants with bronchopulmonary dysplasia
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 .
Retinol deficiency in preterm infants with intraventricular hemorrhage
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 .
Mortality of preterm infants
It was planned to check mortality rate in preterm infants with retinol deficiency. Retinol deficiency rate was calculated accordingly Who data.
Secondary Outcome Measures
Full Information
NCT ID
NCT04780958
First Posted
February 24, 2021
Last Updated
March 3, 2021
Sponsor
Ataturk University
Collaborators
Scientific Research Fund of Atatürk University
1. Study Identification
Unique Protocol Identification Number
NCT04780958
Brief Title
Retinol Status in Preterm Infants and Mothers
Official Title
The Effect of Retinol and RBP Levels of Cord Blood and Mothers on Mortality and Morbidity in Prematures With 30 Weeks and Lower
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University
Collaborators
Scientific Research Fund of Atatürk University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Retinol and retinol binding protein were studied in the umbilical cord blood of 44 preterm infants with gestation age of < 30 weeks. Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. The rate of transplacental retinol passage was calculated. The demographic data of mother and baby, vitamin use in the mother, antenatal steroid application and diseases diagnosed during pregnancy were recorded. An evaluation was made of the retinol, RBP and factors of the mother and baby affecting the transplacental retinol passage. The relationship between retinol and retinol binding protein levels and neonatal mortality and morbidity was investigated.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin A Deficiency
Keywords
Retinol, Preterm infant, Morbidity, Placenta
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study population
Arm Type
Other
Arm Description
During the study period, babies born at this hospital with a gestational week of <30 were included .
Intervention Type
Other
Intervention Name(s)
Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.
Intervention Description
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)
Primary Outcome Measure Information:
Title
Retinol deficiency status in preterm infants and mothers
Description
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.
Time Frame
4 months
Title
Retinol deficiency in preterm infants with respiratory distress syndrome
Description
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 .
Time Frame
3 months
Title
Retinol deficiency in preterm infants with retinopathy of prematurity
Description
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 .
Time Frame
3 months
Title
Retinol deficiency in preterm infants with bronchopulmonary dysplasia
Description
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 .
Time Frame
3 months
Title
Retinol deficiency in preterm infants with intraventricular hemorrhage
Description
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 .
Time Frame
3 months
Title
Mortality of preterm infants
Description
It was planned to check mortality rate in preterm infants with retinol deficiency. Retinol deficiency rate was calculated accordingly Who data.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Minutes
Maximum Age & Unit of Time
10 Minutes
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kadir Ş Tekgündüz, Assoc.Prof
Organizational Affiliation
Atatürk University
Official's Role
Study Director
Facility Information:
Facility Name
Ataturk University Medical Faculty
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey
12. IPD Sharing Statement
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Retinol Status in Preterm Infants and Mothers
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