NCT03691233

Brief Summary

The aim of this clinical audit is to assess the degree of adherence of medical physicians in Assiut university children hospital protocol for diagnosis and management of neonatal shock to the international guidelines.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

12 months

First QC Date

September 19, 2018

Last Update Submit

September 25, 2018

Conditions

Neonatal Disorder

Outcome Measures

Primary Outcomes (1)

  • Evaluation of healthcare providers by evaluating how much diagnosis and management of neonatal shock adherent to Assuit University Children Hospital guidelines.

    analysis of results and compare them to guidelines

    Baseline

Interventions

Clinical audit on diagnosis and management of neonatal shockDRUG

intervenous

Also known as: fliuds

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The neonates who are admitted to neonatology Unit at Assiut University Children Hospital through this period

You may qualify if:

  • All neonates (preterm or full term) who are developing shock

You may not qualify if:

  • Neonates with multiple congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Bhat BV, Plakkal N. Management of Shock in Neonates. Indian J Pediatr. 2015 Oct;82(10):923-9. doi: 10.1007/s12098-015-1758-7. Epub 2015 May 21.

    PMID: 25990594BACKGROUND

  • de Boode WP, van der Lee R, Horsberg Eriksen B, Nestaas E, Dempsey E, Singh Y, Austin T, El-Khuffash A; European Special Interest Group 'Neonatologist Performed Echocardiography' (NPE). The role of Neonatologist Performed Echocardiography in the assessment and management of neonatal shock. Pediatr Res. 2018 Jul;84(Suppl 1):57-67. doi: 10.1038/s41390-018-0081-1.

    PMID: 30072807BACKGROUND

  • Osborn DA, Evans N. Early volume expansion versus inotrope for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2001;2001(2):CD002056. doi: 10.1002/14651858.CD002056.

    PMID: 11406028BACKGROUND

  • Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, Chan HB, Lam CW, Lee BS, Fok TF. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics. 2006 Feb;117(2):367-75. doi: 10.1542/peds.2005-0869.

    PMID: 16452355BACKGROUND

  • Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.

    PMID: 22161578BACKGROUND

  • Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15.

    PMID: 24247112BACKGROUND

  • Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.

    PMID: 19325359BACKGROUND

  • Osborn DA, Evans N. Early volume expansion for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2004;2004(2):CD002055. doi: 10.1002/14651858.CD002055.pub2.

    PMID: 15106166BACKGROUND

  • Subhedar NV, Shaw NJ. Dopamine versus dobutamine for hypotensive preterm infants. Cochrane Database Syst Rev. 2003;(3):CD001242. doi: 10.1002/14651858.CD001242.

    PMID: 12917901BACKGROUND

Related Links

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Safwat M Abd Al-ziz, lecture

    Safwatabdelaziz371@yahoo.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nagwa Ali Mohamed, professer

CONTACT

01096260950Namma65@yahoo.com

Safwat M Abd Al-ziz, lecture

CONTACT

01003918080Safwatabdelaziz371@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 19, 2018

First Posted

October 1, 2018

Study Start

November 1, 2018

Primary Completion

October 30, 2019

Study Completion

December 30, 2019

Last Updated

October 1, 2018

Record last verified: 2018-09