Retinol Status in Preterm Infants and Mothers

March 3, 2021 updated by: Kadir Şerafettin Tekgündüz, Ataturk University

The Effect of Retinol and RBP Levels of Cord Blood and Mothers on Mortality and Morbidity in Prematures With 30 Weeks and Lower

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.

Study Overview

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

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Erzurum, Turkey, 25100
        • Ataturk University Medical Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 minutes to 10 minutes (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 .
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)

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.
4 months
Retinol deficiency in preterm infants with respiratory distress syndrome
Time Frame: 3 months
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 .
3 months
Retinol deficiency in preterm infants with retinopathy of prematurity
Time Frame: 3 months
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 .
3 months
Retinol deficiency in preterm infants with bronchopulmonary dysplasia
Time Frame: 3 months
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 .
3 months
Retinol deficiency in preterm infants with intraventricular hemorrhage
Time Frame: 3 months
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 .
3 months
Mortality of preterm infants
Time Frame: 3 months
It was planned to check mortality rate in preterm infants with retinol deficiency. Retinol deficiency rate was calculated accordingly Who data.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kadir Ş Tekgündüz, Assoc.Prof, Ataturk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2020

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

January 31, 2021

Study Registration Dates

First Submitted

February 24, 2021

First Submitted That Met QC Criteria

March 1, 2021

First Posted (ACTUAL)

March 4, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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