Retinol Status in Preterm Infants and Mothers

NCT04780958 | Completed

• 1 other identifier: TTU-2020-8630
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitamin A Deficiency

Keywords

Retinol; Preterm infant; Morbidity; Placenta

Outcome Measures

Primary Outcomes (6)

• 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.

  4 months

• 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 .

  3 months

• 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 .

  3 months

• 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 .

  3 months

• 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 .

  3 months

• 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.

  3 months

Study Arms (1)

Study population

OTHER

During the study period, babies born at this hospital with a gestational week of \<30 were included .

Other: Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.

Interventions

Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay. OTHER

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)

Study population

Eligibility Criteria

• Age: 5 Minutes - 10 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Babies born l with a gestational week of \<30 and their mothers were included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University Medical Faculty

Erzurum, 25100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Vitamin A Deficiency; Premature Birth

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kadir Ş Tekgündüz, Assoc.Prof

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 4, 2021
• Study Start: June 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

TU (1)