Neonatal PneumoniaNCT06599125
Risk Factors of Mortality in Neonatal Pneumonia
An observational study of Neonatal Pneumonia, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Pneumonia
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Risk factors of mortality in neonatal pneumonia
Who may be able to join
- Newborn aged ≤ 30 days (0 to 30d.)
- Neonates diagnosed with pneumonia during the first month of life.
Who cannot join
- Infant aged more than one month.
- Neonates with ches x-ray negative for pneumonia.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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 \< 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.
- Conditions
- Neonatal Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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% .
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal PneumoniaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hossam El-deen Kheder, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599125
- Sponsor's protocol ID
- neonatal pneumonia
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39087803Hug 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.
PubMed 31097275Baseer 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.
PubMed 32140431
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Mortality in Neonatal Pneumonia
- ClinicalTrials.gov ID
- NCT06599125
- Acronym / sponsor ID
- neonatal pneumonia
- Conditions
- Neonatal Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \< 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Risk factors of mortality in neonatal pneumonia
Key inclusion criteria (2 listed)
- Newborn aged ≤ 30 days (0 to 30d.)
- Neonates diagnosed with pneumonia during the first month of life.
Key exclusion criteria (2 listed)
- Infant aged more than one month.
- Neonates with ches x-ray negative for pneumonia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Methods
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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% .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 39087803North 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.
- Background: PubMed 31097275Hug 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.
- Results publication: PubMed 32140431Baseer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Pneumonia, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Hossam El-deen Kheder (+201153380315, ahmedhossameldien97@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methods (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06599125, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.