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

NCT04769661 | Unknown

• 1 other identifier: RCPR
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Cytokines DIAGNOSTIC_TEST

Doing cord blood cytokines level in preterm infants

Eligibility Criteria

• Age: Up to 1 Hour
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• presence of major congenital anomaly Presence of life threatening conditions

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Retinopathy of Prematurity

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• yasser farouk, lecturer

  assiut university children hospital

  STUDY DIRECTOR

Central Study Contacts

Rewaa Mohammed

CONTACT

01011717820; rewaamohammed2@yahoo.com

gafar ibrahim, prof

CONTACT

01020627864; gafaribrahim2015@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Role of cord blood cytokines and perinatal factors in prediction of retinopathy of prematurity

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 24, 2021
• Study Start: May 1, 2021
• Primary Completion: May 30, 2022
• Study Completion: December 30, 2022
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 year
• Access Criteria: Through finding the research on clinical trials.gov