Clinical trial NCT06599125: Risk Factors of Mortality in Neonatal Pneumonia
Official title: Risk Factors of Mortality in Neonatal Pneumonia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Pneumonia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 85
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Risk factors of mortality in neonatal pneumonia

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.

Detailed description: Neonatal pneumonia, a lower chest infectious disease, is one of the most serious and fatal diseases in young infants. Neonates may catch pneumonia vertically from mother or horizontally from the environment at birth time. Time of catching infection can be classified into:

Prenatal; that's intrauterine, it is also called Congenital Pneumonia. The pathogen may investigate the neonatal lung intrauterine through chrioamniotic membranes or trans-placental.

At birth, during the first week after birth Early onset pneumonia, however pathogen mat be from intrauterine or at birth canal; and mostly this type of pneumonia is bacterial.

After the first week of life late onset pneumonia. It is common to be of nosocomial or community acquired.

Neonatal Pneumonia is the second leading cause of death after neonatal sepsis. It accounts for 152,000 to 490,000 of infants aged \&lt; 1 year annually, Research papers reported that in 2016, 2.6 million neonatal deaths were reported representing a global burden of 19 neonatal deaths per 1000 live births and in 2017 the annual neonatal mortality rate NMR was highest in east, west and central Africa. About specific-cause-mortality of these estimations, lower chest infection represented 13.5% of these deaths, and had the highest incidece in the first 28 days of life in live birth.

In the majority of cases, causing pathogen of neonatal pneumonia is viral, however community and hospital acquired pneumonia are frequently bacterial that caused by Haemophilus influenzae, Streptococcus agalactiae or Enterobacteriaceae species. Although pneumonia occurs in all ages, neonatal pneumonia is associated with comorbidities and mortality in age below 59 days.

Lung of newborn is volurnable to pneumonia due to variable risk factors. Some of these factors are attributed to mother, other to neonate and the rest is to labor circumstances. In general, neonate is suseptabile to infection due to weak immunity; a factor that is more potentiating in premature neonate. However, maternal risk factors resulting in congenital pneumonia are for example represented in systemic diseases, infection during pregnancy as toxoplasmosis, cytomegalovirus CMV, herpes simplex virus HSV. Neonates catch early onset pneumonia in perinatal duration whether before labor through placenta, ascending infection intrauterine or from pathogens in birth canal during vaginal delivery. Late onset pneumonia is due to exposure to the pathogen in community, although, a common risk factor for late onset pneumonia is low birth weight and prematurity.Reported factors that potentiate mortality in case pneumonia are living in developing countries, drining infested water, maternal smoking, late starting of treatment and the more younger of child the higher risk they are in.

Diagnosis of neonatal pneumonia is difficult in neonates because they may experience no symptoms, or have symptoms that are part of other syndromes unlike older children or adults that have clear symptoms. In this study we 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Methods
timeFrame: Baseline
measure: History
timeFrame: Baseline
measure: Examination
timeFrame: Baseline
measure: Investigations
timeFrame: Baseline
measure: Sample size
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.