Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.

NCT05806684 | Unknown

• 1 other identifier: biliROP
• Study Type: observational
• Target: 1,586
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this retrospective observational study is to \[learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants. The main question it aims to answer are: • To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.

Conditions

ROP; Jaundice, Neonatal; Premature; Very Low Birth Weight Infant; ELBW - Extremely Low Birth Weight Infant; Blindness

Outcome Measures

Primary Outcomes (3)

• Number of subjects who developed Retinopathy of Prematurity (ROP) (divided by severity)

  Retinopathy of Prematurity (ROP)

  between 01/01/2010 and 12/31/2020

• Number of subjects who developed jaundice

  Jaundice

  between 01/01/2010 and 12/31/2020

• Duration of jaundice (days) for each subject

  Days of jaundice

  between 01/01/2010 and 12/31/2020

Study Arms (2)

Prematures with jaundice and ROP

Correlation between neonatal indirect bilirubin jaundice and ROP.

Other: ROP

Prematures with ROP without jaundice.

Infants who, despite presenting ROP, did not develop jaundice.

Other: ROP

Interventions

ROP OTHER

Correlation between neonatal indirect bilirubin jaundice and ROP.

Also known as: Jaundice

Prematures with ROP without jaundice.; Prematures with jaundice and ROP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Prematures infants with Gestational age \< 32 weeks and/or birth weight \< 1500g

You may qualify if:

• Gestational age \< 32 weeks
• birth weight \< 1500g

You may not qualify if:

• lack of data regarding the development of ROP
• lack of data on the development of jaundice.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Milan, MI, 20129, Italy

Location

Related Publications (15)

• Stocker R, Glazer AN, Ames BN. Antioxidant activity of albumin-bound bilirubin. Proc Natl Acad Sci U S A. 1987 Aug;84(16):5918-22. doi: 10.1073/pnas.84.16.5918.

  PMID: 3475708 RESULT

• Hammermann C, Goldstein R, Kaplan M, Eran M, Goldschmidt D, Eidelman AI. Bilirubin in the premature: toxic waste or natural defense? Clin Chem. 1998 Dec;44(12):2551-3. No abstract available.

  PMID: 9882171 RESULT

• Hegyi T, Goldie E, Hiatt M. The protective role of bilirubin in oxygen-radical diseases of the preterm infant. J Perinatol. 1994 Jul-Aug;14(4):296-300.

  PMID: 7965225 RESULT

• Gopinathan V, Miller NJ, Milner AD, Rice-Evans CA. Bilirubin and ascorbate antioxidant activity in neonatal plasma. FEBS Lett. 1994 Aug 1;349(2):197-200. doi: 10.1016/0014-5793(94)00666-0.

  PMID: 8050565 RESULT

• Teng RJ, Wu TJ, Yau KI. Retinopathy of prematurity in very-low-birthweight neonates: epidemiology and risk factors. Zhonghua Min Guo Xiao Er Ke Yi Xue Hui Za Zhi. 1997 Sep-Oct;38(5):370-4.

  PMID: 9401181 RESULT

• Dani C, Martelli E, Bertini G, Pezzati M, Filippi L, Rossetti M, Rizzuti G, Rubaltelli FF. Plasma bilirubin level and oxidative stress in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2003 Mar;88(2):F119-23. doi: 10.1136/fn.88.2.f119.

  PMID: 12598500 RESULT

• Yigit S, Yurdakok M, Kilin K, Oran O, Erdem G, Tekinalp G. Serum malondialdehyde concentration in babies with hyperbilirubinaemia. Arch Dis Child Fetal Neonatal Ed. 1999 May;80(3):F235-7. doi: 10.1136/fn.80.3.f235.

  PMID: 10212090 RESULT

• Benaron DA, Bowen FW. Variation of initial serum bilirubin rise in newborn infants with type of illness. Lancet. 1991 Jul 13;338(8759):78-81. doi: 10.1016/0140-6736(91)90074-y.

  PMID: 1676469 RESULT

• Shekeeb Shahab M, Kumar P, Sharma N, Narang A, Prasad R. Evaluation of oxidant and antioxidant status in term neonates: a plausible protective role of bilirubin. Mol Cell Biochem. 2008 Oct;317(1-2):51-9. doi: 10.1007/s11010-008-9807-4. Epub 2008 Jun 17.

  PMID: 18560765 RESULT

• Gabbianelli M, Testa U, Morsilli O, Pelosi E, Saulle E, Petrucci E, Castelli G, Giovinazzi S, Mariani G, Fiori ME, Bonanno G, Massa A, Croce CM, Fontana L, Peschle C. Mechanism of human Hb switching: a possible role of the kit receptor/miR 221-222 complex. Haematologica. 2010 Aug;95(8):1253-60. doi: 10.3324/haematol.2009.018259. Epub 2010 Mar 19.

  PMID: 20305142 RESULT

• De Halleux V, Truttmann A, Gagnon C, Bard H. The effect of blood transfusion on the hemoglobin oxygen dissociation curve of very early preterm infants during the first week of life. Semin Perinatol. 2002 Dec;26(6):411-5. doi: 10.1053/sper.2002.37313.

  PMID: 12537312 RESULT

• Barkemeyer BM, Hempe JM. Effect of transfusion on hemoglobin variants in preterm infants. J Perinatol. 2000 Sep;20(6):355-8. doi: 10.1038/sj.jp.7200392.

  PMID: 11002873 RESULT

• Pheng E, Lim ZD, Tai Li Min E, Rostenberghe HV, Shatriah I. Haemoglobin Levels in Early Life among Infants with and without Retinopathy of Prematurity. Int J Environ Res Public Health. 2021 Jul 1;18(13):7054. doi: 10.3390/ijerph18137054.

  PMID: 34280989 RESULT

• Hellstrom W, Martinsson T, Morsing E, Granse L, Ley D, Hellstrom A. Low fraction of fetal haemoglobin is associated with retinopathy of prematurity in the very preterm infant. Br J Ophthalmol. 2022 Jul;106(7):970-974. doi: 10.1136/bjophthalmol-2020-318293. Epub 2021 Feb 5.

  PMID: 33547036 RESULT

• Fierson WM; American Academy of Pediatrics Section on Ophthalmology; American Academy of Ophthalmology; American Association for Pediatric Ophthalmology and Strabismus; American Association of Certified Orthoptists. Screening Examination of Premature Infants for Retinopathy of Prematurity. Pediatrics. 2018;142(6):e20183061. Pediatrics. 2019 Mar;143(3):e20183810. doi: 10.1542/peds.2018-3810. No abstract available.

  PMID: 30824604 RESULT

MeSH Terms

Conditions

Jaundice, Neonatal; Premature Birth; Blindness

Condition Hierarchy (Ancestors)

Hyperbilirubinemia, Neonatal; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms

Study Officials

• Giacomo Cavallaro, MD, PhD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  STUDY DIRECTOR

• Silvia Gulden, MD

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giacomo Cavallaro, MD, PhD

CONTACT

+390255032234; giacomo.cavallaro@policlinico.mi.it

Silvia Gulden, MD

CONTACT

+390255032234; silvia.gulden@hotmail.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 10, 2023
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2024
• Last Updated: April 24, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)