Risk Factors of Mortality in Neonatal Pneumonia

NCT06599125 | Not Yet Recruiting DMC

• 1 other identifier: neonatal pneumonia
• Study Type: observational
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief Summary

Neonatal pneumonia, a lower chest infectious disease, is one of the most serious and fatal diseases in young infants.(1) Neonates may catch pneumonia vertically from mother or horizontally from the environment at birth time.

Conditions

Neonatal Pneumonia

Outcome Measures

Primary Outcomes (5)

• Methods

  Our study will be retrospective cross sectional study,and the cases will be collected from archive of neonatology unit of assiut university children hospital as well as prospective single group cohort study and will be conducted in neonatalogy unit in Children Hospital in Assiut University for one year duration. Newborn babies aged since birth to ≤ 28 days who have been diagnosed with pneumonia will be included.

  Baseline

• History

  Full history will be taken from all patient with emphasis on the following : Maternal history: Demographic history 1- Maternal age 3-- socioeconomic state Medical conditions: Any infection during pregnancy. Events during pregnancy (e.g. PROM, pre-eclampsia, Gestationale diabetes, …). Autoimmune diseases. Any comorbid disease that affect immunity (DM, CKD, etc. …). Surgical history: Any operation conducted during pregnancy. Blood transfusion (during pregnancy). Obstetric history: Mode of labor ( Cesarean / Vaginal). Maternal fever Parity. Neonatal history: Time of diagnosis (prenatal- at birth- first day- second day- … - 30th day) Signs of hypoxia at birth (cyanosis- respiratory distress- ……) Tachypnea Fever Admission in NICU

  Baseline

• Examination

  General and local examination will be done to all patient with emphasis on the following: Oxygen saturation. Temperature. Centeral and Peripheral Cyanosis. Congenital anomalies. Chest examination: Inspection: Deformity of thorax. / Shape of the thorax (Deformity, Movement,…) Signs of distress (tachypnea, nasal flaring, Lower chest indrawing). Respiratory rate Palpation Percution Auscultation: Breathing sounds. Decreased air entry Rales or ronchi Crepitation

  Baseline

• Investigations

  All patients will be subjectd to the following investigations: Complete blood count (CBC) for neonate. Chest X-ray. Blood culture. C- reactive protein. ESR Serum Na, K. Kidney Function Test (KFT) Liver Function Test (LFT) Some of cases will be subjectd to the following investigations according to the clinical status : CT - Chest Echocardiograpgy Bronchoalveolar lavage Neonatal Pneumonia Mortality will be considered as death occurring in pneumonic neonate during their first month of life while hospitalization.

  Baseline

• Sample size

  Based on determining the main outcome variable, The estimated minimum required sample size is 85 patients . The sample size was calculated using Epi-info version 7 software, based on the following assumptions:Main outcome variable is aim to evaluate the clinical, laboratory, radiological and other risk factors that predict mortality in term and preterm (32 to 36 weeks) neonates admitted with pneumonia in neonatalogy unit in Assuit university Children hospital.Based on previous studies (7), The prevalence of neonatal pneumonia in Egypt varies by region and study. In a study conducted at Qena University Hospital, neonatal pneumonia was found in 17.2% of neonates admitted with respiratory diseases and based on the percentage confidence limits of 5% and a Confidence level=80% .

  Baseline

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Risk factors of mortality in neonatal pneumonia

You may qualify if:

• Newborn aged ≤ 30 days (0 to 30d.)
• Neonates diagnosed with pneumonia during the first month of life.

You may not qualify if:

• Infant aged more than one month.
• Neonates with ches x-ray negative for pneumonia.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• North K, Frade Garcia A, Crouch M, Kimsen S, Hoey A, Wade C, Kim Y, Chou R, Edmond KM, Lee ACC, Rees CA. Efficacy of Antibiotic Regimens for Pneumonia in Young Infants Aged 0-59 Days: A Systematic Review. Pediatrics. 2024 Aug 1;154(Suppl 1):e2024066588G. doi: 10.1542/peds.2024-066588G.

  PMID: 39087803 BACKGROUND

• Hug L, Alexander M, You D, Alkema L; UN Inter-agency Group for Child Mortality Estimation. National, regional, and global levels and trends in neonatal mortality between 1990 and 2017, with scenario-based projections to 2030: a systematic analysis. Lancet Glob Health. 2019 Jun;7(6):e710-e720. doi: 10.1016/S2214-109X(19)30163-9.

  PMID: 31097275 BACKGROUND

• Baseer KAA, Mohamed M, Abd-Elmawgood EA. Risk Factors of Respiratory Diseases Among Neonates in Neonatal Intensive Care Unit of Qena University Hospital, Egypt. Ann Glob Health. 2020 Feb 26;86(1):22. doi: 10.5334/aogh.2739.

  PMID: 32140431 RESULT

Central Study Contacts

Ahmed Hossam El-deen Kheder

CONTACT

+201153380315; ahmedhossameldien97@gmail.com

Abdellatif Mohamed Abo El Gheet

CONTACT

01005208016; a.m.abdelmoez@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515, Assuit

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09