Neonatal DiseaseNCT04279301
Neonatal Admission in Assuit University Children Hospital
An observational study of Neonatal Disease, run by Assiut University.
Trial summary
There are many causes of admission of neonates in Neonatal Intensive Care Unit.So knowing such causes and their outcomes will give us knowledge about different risk factors of each disease and the prognosis of each cause. Read more about this study
- Who is it for?
- Ages 1 hour to 1 month
- Conditions the study is for
- Neonatal Disease
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2021to 1 Dec 2021
- 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 hour to 1 month
- All sexes
- Child
Study population: Neonates delivered in Assuit University Hospital and need admission in neonatology unit of Assuit University Children Hospital.
Who may be able to join
- All neonates delivered in Assuit University Hospital and admitted at NICU of Assuit University Children Hospital.
Who cannot join
- Patients delivered outside Assuit University Hospital.
- Patients with missing diagnosis or died before reaching diagnosis.
- Patients with missing clinical outcomes.
- Patients admitted for observation and discharged at the same day of admission.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Causes and Outcomes of Neonatal Admission in Neonatal Intensive Care Unit of Assuit University Children Hospital(AUCH)
There are many causes of admission of neonates in Neonatal Intensive Care Unit.So knowing such causes and their outcomes will give us knowledge about different risk factors of each disease and the prognosis of each cause.
Read the detailed description
The rapid decline in neonatal mortality during the past 4 decades has been attributed to improvements in neonatal intensive care. This decline was attributable to improved condition of the infants on NICU(Neonatal Intensive Care Unit) admission (improved birth weight, higher Apgar scores, and better physiologic ability).
There are multiple risk factors related to admission of newborns at NICU as low birth weight , neonatal sepsis , hypothermia , hypoglycemia , respiratory distress and other factors. These risk factors are also considered as causes of death beside prematurity and congenital malformations.
One of the most important risk factors for admission and is considered as a major cause of death is premature infants. Neonatal intensive care has become a cornerstone for treatment of premature infants worldwide.
Another group is low birth weight (LBW) infants. LBW babies face increased risk of a myriad of physical and developmental problems. Before the era of neonatal intensive care units, few VLBW infants survived. Today, babies who weigh as little as a pound and developed in the uterus for as early as 26 weeks have been known to survive. LBW babies need high cost of intensive neonatal care and adequate nursing coverage.
Neonatal respiratory morbidity in term infants is another cause of admission and death in neonates and is multifactorial in aetiology.
Neonatal sepsis as well is one of the most common reasons for admission to neonatal units in developing countries. It is also a major cause of mortality in both developed and developing countries.
Hypoglycaemia also plays an important role as it accounts for approximately one-tenth of term admissions to neonatal units can cause long-term neurodevelopmental impairment and is associated with the significant burden to the affected infants, families and the health system.
Knowing the disease patterns and causes in the neonatology unit and the disease-wise outcome can inform the required efforts to reduce morbidity and mortality. Thus, in this study we will assess the causes and risk factors for neonatal admission at NICU of Assuit University Children Hospital (AUCH) and the outcome of them.
- Conditions
- Neonatal Disease
- Keywords
- Neonatal morbidity
- Medical subject headings
- Infant, Newborn, Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of cause of admission of neonate in Neonatology Unit and the outcome of this cause
Analysis of these causes and their outcomes
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start1 Mar 2021 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal DiseaseStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Naguib Khairy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279301
- Sponsor's protocol ID
- Neonatal admission in AUCH
- Status last verified
- Jan 2021
- First submitted
- 19 Feb 2020
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Seid SS, Ibro SA, Ahmed AA, Olani Akuma A, Reta EY, Haso TK, Fata GA. Causes and factors associated with neonatal mortality in Neonatal Intensive Care Unit (NICU) of Jimma University Medical Center, Jimma, South West Ethiopia. Pediatric Health Med Ther. 2019 May 3;10:39-48. doi: 10.2147/PHMT.S197280. eCollection 2019.
PubMed 31191085Quinn CE, Sivasubramaniam P, Blevins M, Al Hajajra A, Znait AT, Khuri-Bulos N, Faouri S, Halasa N. Risk factors for neonatal intensive care unit admission in Amman, Jordan. East Mediterr Health J. 2016 Jun 15;22(3):163-74. doi: 10.26719/2016.22.3.163.
PubMed 27334073Goswami IR, Ghosh JK, Sinha MK, Begum H, Chatterjee S. Can the special care neonatal unit admission cut-off be lowered down to 1500g babies? Indian J Pediatr. 2009 Sep;76(9):937-9. doi: 10.1007/s12098-009-0185-z. Epub 2009 Nov 4.
PubMed 19904507Alkiaat A, Hutchinson M, Jacques A, Sharp MJ, Dickinson JE. Evaluation of the frequency and obstetric risk factors associated with term neonatal admissions to special care units. Aust N Z J Obstet Gynaecol. 2013 Jun;53(3):277-82. doi: 10.1111/ajo.12070. Epub 2013 Mar 13.
PubMed 23731095Quddus AR, Islam MN, Uddin MB, Mahmud AA, Badruzzaman M, Saha SK, Sattar S, Afreen KF. Study of Risk Factors, Causative Organisms & Their Sensitivity Pattern in Neonatal Sepsis in a Community Based Tertiary Level Hospital. Mymensingh Med J. 2019 Oct;28(4):839-848.
PubMed 31599249Dassios T, Greenough A, Leontiadi S, Hickey A, Kametas NA. Admissions for hypoglycaemia after 35 weeks of gestation: perinatal predictors of cost of stay. J Matern Fetal Neonatal Med. 2019 Feb;32(3):448-454. doi: 10.1080/14767058.2017.1381905. Epub 2018 Jan 31.
PubMed 28922987
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Outcomes of Neonatal Admission in Neonatal Intensive Care Unit of Assuit University Children Hospital(AUCH)
- ClinicalTrials.gov ID
- NCT04279301
- Acronym / sponsor ID
- Neonatal admission in AUCH
- Conditions
- Neonatal Disease
- Keywords
- Neonatal morbidity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 21 Feb 2020 (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.
There are many causes of admission of neonates in Neonatal Intensive Care Unit.So knowing such causes and their outcomes will give us knowledge about different risk factors of each disease and the prognosis of each cause.
Detailed description
The rapid decline in neonatal mortality during the past 4 decades has been attributed to improvements in neonatal intensive care. This decline was attributable to improved condition of the infants on NICU(Neonatal Intensive Care Unit) admission (improved birth weight, higher Apgar scores, and better physiologic ability).
There are multiple risk factors related to admission of newborns at NICU as low birth weight , neonatal sepsis , hypothermia , hypoglycemia , respiratory distress and other factors. These risk factors are also considered as causes of death beside prematurity and congenital malformations.
One of the most important risk factors for admission and is considered as a major cause of death is premature infants. Neonatal intensive care has become a cornerstone for treatment of premature infants worldwide.
Another group is low birth weight (LBW) infants. LBW babies face increased risk of a myriad of physical and developmental problems. Before the era of neonatal intensive care units, few VLBW infants survived. Today, babies who weigh as little as a pound and developed in the uterus for as early as 26 weeks have been known to survive. LBW babies need high cost of intensive neonatal care and adequate nursing coverage.
Neonatal respiratory morbidity in term infants is another cause of admission and death in neonates and is multifactorial in aetiology.
Neonatal sepsis as well is one of the most common reasons for admission to neonatal units in developing countries. It is also a major cause of mortality in both developed and developing countries.
Hypoglycaemia also plays an important role as it accounts for approximately one-tenth of term admissions to neonatal units can cause long-term neurodevelopmental impairment and is associated with the significant burden to the affected infants, families and the health system.
Knowing the disease patterns and causes in the neonatology unit and the disease-wise outcome can inform the required efforts to reduce morbidity and mortality. Thus, in this study we will assess the causes and risk factors for neonatal admission at NICU of Assuit University Children Hospital (AUCH) and the outcome of them.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 hour to 1 month
- Sex
- All
- Age groups
- Child
- Study population
- Neonates delivered in Assuit University Hospital and need admission in neonatology unit of Assuit University Children Hospital.
Key inclusion criteria (1 listed)
- All neonates delivered in Assuit University Hospital and admitted at NICU of Assuit University Children Hospital.
Key exclusion criteria (4 listed)
- Patients delivered outside Assuit University Hospital.
- Patients with missing diagnosis or died before reaching diagnosis.
- Patients with missing clinical outcomes.
- Patients admitted for observation and discharged at the same day of admission.
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
Detection of cause of admission of neonate in Neonatology Unit and the outcome of this cause
Time frame: baseline
Analysis of these causes and their outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Background: PubMed 31191085Seid SS, Ibro SA, Ahmed AA, Olani Akuma A, Reta EY, Haso TK, Fata GA. Causes and factors associated with neonatal mortality in Neonatal Intensive Care Unit (NICU) of Jimma University Medical Center, Jimma, South West Ethiopia. Pediatric Health Med Ther. 2019 May 3;10:39-48. doi: 10.2147/PHMT.S197280. eCollection 2019.
- Background: PubMed 27334073Quinn CE, Sivasubramaniam P, Blevins M, Al Hajajra A, Znait AT, Khuri-Bulos N, Faouri S, Halasa N. Risk factors for neonatal intensive care unit admission in Amman, Jordan. East Mediterr Health J. 2016 Jun 15;22(3):163-74. doi: 10.26719/2016.22.3.163.
- Background: PubMed 19904507Goswami IR, Ghosh JK, Sinha MK, Begum H, Chatterjee S. Can the special care neonatal unit admission cut-off be lowered down to 1500g babies? Indian J Pediatr. 2009 Sep;76(9):937-9. doi: 10.1007/s12098-009-0185-z. Epub 2009 Nov 4.
- Background: PubMed 23731095Alkiaat A, Hutchinson M, Jacques A, Sharp MJ, Dickinson JE. Evaluation of the frequency and obstetric risk factors associated with term neonatal admissions to special care units. Aust N Z J Obstet Gynaecol. 2013 Jun;53(3):277-82. doi: 10.1111/ajo.12070. Epub 2013 Mar 13.
- Background: PubMed 31599249Quddus AR, Islam MN, Uddin MB, Mahmud AA, Badruzzaman M, Saha SK, Sattar S, Afreen KF. Study of Risk Factors, Causative Organisms & Their Sensitivity Pattern in Neonatal Sepsis in a Community Based Tertiary Level Hospital. Mymensingh Med J. 2019 Oct;28(4):839-848.
- Background: PubMed 28922987Dassios T, Greenough A, Leontiadi S, Hickey A, Kametas NA. Admissions for hypoglycaemia after 35 weeks of gestation: perinatal predictors of cost of stay. J Matern Fetal Neonatal Med. 2019 Feb;32(3):448-454. doi: 10.1080/14767058.2017.1381905. Epub 2018 Jan 31.
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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 Disease, 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 1 inclusion and 4 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 Jan 2021. 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 Mohamed Naguib Khairy, M.B.B.Ch (+201091921973, mohamed_ibrahim@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of cause of admission of neonate in Neonatology Unit and the outcome of this cause (time frame: baseline). 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 NCT04279301, which also lists 6 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 Jan 2021.