Role of Cord Blood Cytokines and Perinatal Factors in Prediction of Retinopathy of Prematurity

Cord blood will be taken after birth for evaluation of cytokines level. At age of 4-6 weeks, we will do fundus examination for babies . Retrograde, we will study the perinatal risk factors in subjects found to have retinopathy. Follow up fundus will be done according to results of the first examination. By this study,we will be able later on to predict whom of preterm infants are more prone to develop retinopathy of prematurity.

Study Overview

• Status: Unknown
• Conditions: Retinopathy of Prematurity
• Intervention / Treatment: Diagnostic test: Cytokines

Detailed Description

All patients will be subjected to the following:

1. Clinical evaluation:

   • History taking including name, sex and age at diagnosis of ROP.
   • Detailed obstetric history [maternal age, type of conception (natural, hormonal or in vitro fertilization), type of delivery (vaginal or cesarean section), single or multiple gestation, pregnancy complications (hypertension, diabetes mellitus, placental abruption, premature rupture of membranes, chorioamnionitis), drug history including steroid treatment received prior to delivery].
   • Neonatal data [Gestational age by weeks calculated from the last menstrual period and confirmed by physical examination, birth weight in grams, Apgar scores at 1 and 5 minutes, weight appropriate or small for gestational age, presence of hypoxia during or after delivery, need for oxygen therapy (mode of delivery, duration, oxygen saturation), presence of clinical sepsis, Respiratory distress syndrome, anemia or the need of blood transfusion].
   • Complete physical examination will be done to all babies including cardiac, chest, abdominal and neurological examination.
2. Laboratory assessment:

A- Routine assessment:

1. Complete blood count (CBC) for the mother.
2. CBC for all infants.

B- Immunological assessment: level of Interleukin-6 and 8, and Tumor necrosis factor-α will be assessed:

Umbilical cord blood will be sampled by venipuncture of umbilical vein at birth under complete aseptic conditions for determination of cytokine level. Cord blood samples will be collected on serum separator tube with gel and then are allowed to clot for 30 minutes at room temperature before centrifugation for 15 minutes at 1000xg. Serum will be removed and stored at ≤ -20 ˚c.till assessment by Lab-scan 3D using Luminex assay multiplex kits

3- Fundus examination After training on fundus examination at ophthalmology department, I will do it for babies. Current guidelines by the American Academy of Ophthalmology and Pediatrics, and American Association for Pediatric Ophthalmology and Strabismus recommend that all infants with gestational age ≤32 weeks or birth weight ≤1500g should be screened for retinopathy of prematurity (ROP). Unnecessary examinations may increase the medical costs for ROP screening. First examination will be done at age of 4 to 6 weeks of age, then every 2-3 weeks until their vessels have grown out to the ora serrate and the retina is considered mature. If ROP is diagnosed, examination will be done every 1-2 weeks according to the severity of the disease. The stage of ROP is the highest stage during all fundus examinations done.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Rewaa Mohammed; Phone Number: 01011717820; Email: rewaamohammed2@yahoo.com
• Study Contact Backup: Name: gafar ibrahim, prof; Phone Number: 01020627864; Email: gafaribrahim2015@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 hour (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Preterm babies with the previous eligible criteria who were delivered in Women's health hospital and admitted to neonatal intensive care unit of assiut pediatric hospital

Description

Inclusion Criteria:

• gestational age less than 32 weeks Birth weight less than 1.5kg

Exclusion Criteria:

• presence of major congenital anomaly Presence of life threatening conditions

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of retinopathy of prematurity	Measure incidence of retinopathy of prematurity in preterm infants	1 year
Association of cord blood cytokines and perinatal factors and retinopathy of prematurity	Discover if association exists between cord blood cytokines and perinatal factors and the occurence of retinopathy of prematurity	1 year

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: yasser farouk, lecturer, Assiut university children hospital

Publications and helpful links

General Publications

• 1. Zin A, Gole GA. Retinopathy of prematurity-incidence today. Clin Perinatol. 2013;40:185-200. PMID: 23719304 DOI: 10.1016/j.clp.2013.02.001 2. Blencowe H, Lawn JE, Vazquez T, Fielder A, Gilbert C. Preterm-associated visual impairment and estimates of retinopathy of prematurity at regional and global levels for 2010. Pediatr Res. 2013;74(Suppl 1):35-49. Pediatr Res. 2013 Dec;74 Suppl 1(Suppl 1):17-34. doi: 10.1038/pr.2013.204.PMID: 24366461 3. Austeng D, Kallen KB, Ewald UW, Jakobsson PG, Holmstrom GE. Incidence of retinopathy of prematurity in infants born before 27 weeks' gestation in Sweden. Arch Ophthalmol. 2009;127:1315-9. PMID: 19822848 DOI: 10.1001/archophthalmol.2009.244 4. Lynch AM, Wagner BD, Hodges JK, et al. The relationship of the subtypes of preterm birth with retinopathy of prematurity. Am J Obstet Gynecol. 2017;217:354. 9. PMID: 28545834 DOI: 10.1016/j.ajog.2017.05.029

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Retinal Diseases; Premature Birth; Retinopathy of Prematurity
• Other Study ID Numbers: RCPR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make individual participant data (IPD) and related data dictionaries available
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: Through finding the research on clinical trials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No