Risk Factors of Mortality in Neonatal Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 主要终点
- Methods
研究概览
简要总结
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.
详细描述
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 < 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborn aged ≤ 30 days (0 to 30d.)
- •Neonates diagnosed with pneumonia during the first month of life.
排除标准
- •Infant aged more than one month.
- •Neonates with ches x-ray negative for pneumonia.
结局指标
主要结局
Methods
时间窗: Baseline
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.
History
时间窗: Baseline
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
Examination
时间窗: Baseline
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
Investigations
时间窗: Baseline
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.
Sample size
时间窗: Baseline
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% .
次要结局
未报告次要终点
研究者
Ahmed Hossam El-deen Kheder
71515, Assuit
Assiut University