Treatment Outcome With Antibiotic Use and Its Resistance Pattern Among Patient With Neonatal Sepsis

NCT05742477 | Unknown

• 1 other identifier: neonatal sepsis treatment
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Determine Treatment outcome with antibiotic use and its resistance pattern among neonatal sepsis patients

Conditions

Neonatal Sepsis

Keywords

neonatal; sepsis; antibiotics

Outcome Measures

Primary Outcomes (2)

• Sepsis convelence

  It is difined by abcence of fever, jundice, respiratory failure and gastroentritis

  24hours

• Sepsis convelence

  It is difined by abcence of fever, jundice, respiratory failure and gastroentritis

  1 week

Interventions

Antibiotic DRUG

role of antibiotics in treatment of neonatal sepsis

Eligibility Criteria

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

Study Population

patients with neonatal sepsis

You may qualify if:

• Newborn suspected with sepsis diagnosed on the basis of clinical signs and symptoms:
• temperature instability
• feeding problems,
• convulsions,
• lethargy
• respiratory distress.
• laboratory findings such as:
• C-Reactive Protein (CRP)
• complete blood count (CBC)
• blood/urine cultures

You may not qualify if:

• Respiratory distress syndrome
• Congenital pneumonia

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Klein JO. Bacteriology of neonatal sepsis. Pediatr Infect Dis J. 1990 Oct;9(10):778. No abstract available.

  PMID: 2235163 BACKGROUND

• Liu L, Oza S, Hogan D, Chu Y, Perin J, Zhu J, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of under-5 mortality in 2000-15: an updated systematic analysis with implications for the Sustainable Development Goals. Lancet. 2016 Dec 17;388(10063):3027-3035. doi: 10.1016/S0140-6736(16)31593-8. Epub 2016 Nov 11.

  PMID: 27839855 BACKGROUND

• Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.

  PMID: 22579125 BACKGROUND

• Stoll BJ, Hansen NI, Sanchez PJ, Faix RG, Poindexter BB, Van Meurs KP, Bizzarro MJ, Goldberg RN, Frantz ID 3rd, Hale EC, Shankaran S, Kennedy K, Carlo WA, Watterberg KL, Bell EF, Walsh MC, Schibler K, Laptook AR, Shane AL, Schrag SJ, Das A, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues. Pediatrics. 2011 May;127(5):817-26. doi: 10.1542/peds.2010-2217. Epub 2011 Apr 25.

  PMID: 21518717 BACKGROUND

Related Links

• Early onset neonatal sepsis: the burden of group B Streptococcal and E. coli disease continues

MeSH Terms

Conditions

Neonatal Sepsis; Sepsis

Interventions

Anti-Bacterial Agents

Condition Hierarchy (Ancestors)

Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Abd elrahman Ahmed Hussain, resident doctor

CONTACT

0109326627 6; abduahmedh15@gmail.com

Naglaa Abu Fadan, Prof.D.

CONTACT

01004465062; naglaa.ibrahim@med.au.edu.eg

Study Design

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

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: February 24, 2023
• Study Start: March 31, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share