Acute Kidney Injury in Newborns With Perinatal Asphyxia

NCT03617055 | Unknown

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

Brief Summary

The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital

Conditions

Acute Kidney Injury

Keywords

kidney injury, asphyxia,cystatin c

Outcome Measures

Primary Outcomes (1)

• serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia.

  measuring serum cystatin c in neonates with perinatal asphyxia

  one year

Secondary Outcomes (1)

• is to determine the incidence of Acute kidney injury in neonates with perinatal asphyxia.

  one year

Interventions

serum cystatin c DIAGNOSTIC_TEST

Blood sample for serum cystatin c will be taken on the first and third days of life for all neonates with clinical or laboratory signs of perinatal asphyxia who are admitted to NICU for early detection of AKI in the study group.

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

all full term neonates with documented perinatal asphyxiaby by one of the following indicators: (i) Presence of a sentinel hypoxic event immediately before or during delivery; (ii) History of fetal distress (bradycardia, late decelerations, absence of heart rate variability); (iii) Need for neonatal resuscitation at delivery; (iv) 1-min Apgar score \<3 or 5-min Apgar score \<7; or metabolic acidosis (BE \> 10 in cord blood).

You may qualify if:

• all full term neonates who are admitted to neonatal intensive care unit of Assiut University Children Hospital through the period from Jan. 2019 to Jan. 2020 with documented perinatal asphyxia

You may not qualify if:

• preterm neonates \< 37 weeks, neonates who died within the first 24 hours of admission, neonates with any congenital anomalies like skeletal, renal or urinary tract, neonates with AKI for any cause other than asphyxia and neonates with maternal history of renal failure .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (11)

• Abdulkader RC, Liborio AB, Malheiros DM. Histological features of acute tubular necrosis in native kidneys and long-term renal function. Ren Fail. 2008;30(7):667-73. doi: 10.1080/08860220802212460.

  PMID: 18704814 BACKGROUND

• Coca SG, Singanamala S, Parikh CR. Chronic kidney disease after acute kidney injury: a systematic review and meta-analysis. Kidney Int. 2012 Mar;81(5):442-8. doi: 10.1038/ki.2011.379. Epub 2011 Nov 23.

  PMID: 22113526 BACKGROUND

• Mathur NB, Agarwal HS, Maria A. Acute renal failure in neonatal sepsis. Indian J Pediatr. 2006 Jun;73(6):499-502. doi: 10.1007/BF02759894.

  PMID: 16816511 BACKGROUND

• Cuzzolin L, Fanos V, Pinna B, di Marzio M, Perin M, Tramontozzi P, Tonetto P, Cataldi L. Postnatal renal function in preterm newborns: a role of diseases, drugs and therapeutic interventions. Pediatr Nephrol. 2006 Jul;21(7):931-8. doi: 10.1007/s00467-006-0118-2. Epub 2006 May 25.

  PMID: 16773403 BACKGROUND

• Subramanian S, Agarwal R, Deorari AK, Paul VK, Bagga A. Acute renal failure in neonates. Indian J Pediatr. 2008 Apr;75(4):385-91. doi: 10.1007/s12098-008-0043-4. Epub 2008 May 18.

  PMID: 18536895 BACKGROUND

• Bona E, Hagberg H, Loberg EM, Bagenholm R, Thoresen M. Protective effects of moderate hypothermia after neonatal hypoxia-ischemia: short- and long-term outcome. Pediatr Res. 1998 Jun;43(6):738-45. doi: 10.1203/00006450-199806000-00005.

  PMID: 9621982 BACKGROUND

• Oncel MY, Canpolat FE, Arayici S, Alyamac Dizdar E, Uras N, Oguz SS. Urinary markers of acute kidney injury in newborns with perinatal asphyxia (.). Ren Fail. 2016 Jul;38(6):882-8. doi: 10.3109/0886022X.2016.1165070. Epub 2016 Apr 7.

  PMID: 27055689 BACKGROUND

• Durkan AM, Alexander RT. Acute kidney injury post neonatal asphyxia. J Pediatr. 2011 Feb;158(2 Suppl):e29-33. doi: 10.1016/j.jpeds.2010.11.010.

  PMID: 21238703 BACKGROUND

• Bagshaw SM, Bellomo R. Early diagnosis of acute kidney injury. Curr Opin Crit Care. 2007 Dec;13(6):638-44. doi: 10.1097/MCC.0b013e3282f07570.

  PMID: 17975383 BACKGROUND

• Kandasamy Y, Smith R, Wright IM. Measuring cystatin C to determine renal function in neonates. Pediatr Crit Care Med. 2013 Mar;14(3):318-22. doi: 10.1097/PCC.0b013e318271f4a5.

  PMID: 23392363 BACKGROUND

• Jetton JG, Askenazi DJ. Acute kidney injury in the neonate. Clin Perinatol. 2014 Sep;41(3):487-502. doi: 10.1016/j.clp.2014.05.001. Epub 2014 Jul 22.

  PMID: 25155722 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Asphyxia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

nafesa refaat, MD

CONTACT

00201148336224; nrefat@aun.edu.eg

Mohammed amir, MD

CONTACT

00201005689353; m_amir_riad@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohammed Abdel tawab sabra

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 6, 2018
• Study Start: January 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 7, 2018

Record last verified: 2018-07