Neonatal DiseasesNCT05809063
Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals
An observational study of Neonatal Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
The neonatal period considered the time from birth up to the first 28 days of life \& further classified into: Very early birth (birth to < 24 hours). Early birth (24 hours to < 7 days). Late or last neonatal period (7 days to 28 days). Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Diseases
- What is being tested?
- observational
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Study population: - All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.
Who may be able to join
- All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.
Who cannot join
- Failure to obtain consent.
- Neonates need preparation for advanced interventions not available in our unit like cardiac operations.
- Neonates require peritoneal dialysis.
- Traumatic injury.
Trial locations and contacts
1 site in 1 country.
Mohammed A Bakhet, Professor contact
About this study
The neonatal period considered the time from birth up to the first 28 days of life \& further classified into:
- Very early birth (birth to < 24 hours).
- Early birth (24 hours to < 7 days).
- Late or last neonatal period (7 days to 28 days).
Read more
It is characterized by the transition from extra uterine life and rapid growth and development. It is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable.
The pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services.
It varies from place to place and from time to time even in the same locality. Information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality.
To improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. To achieve this goal, it is important to study the pattern of neonatal admissions
- Conditions
- Neonatal Diseases
- Being tested
- observational
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationalOther
document the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units
| Study group | Role | What they receive |
|---|---|---|
| cardiovascular patients | neonates that have cardiovascular diseases Receives: Other: observational | |
| respiratory patients | neonates that have respiratory diseases Receives: Other: observational | |
| gastrointestinal diseases | neonates that havegastrointestinal diseases Receives: Other: observational | |
| renal patients | neonates that have renal diseases Receives: Other: observational | |
| central nervous system diseases | neonates that have central nervous system diseases Receives: Other: observational | |
| metabolic patients | neonates that have metabolic diseases Receives: Other: observational | |
| endocrinal patients | neonates that have endocrinal diseases Receives: Other: observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units
all neonates admitted with respiratory diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with cardiovascular diseases admitted to neonatal intensive care units
all neonates admitted with cardiovascular diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with gastrointestinal diseases admitted to neonatal intensive care units
all neonates admitted with gastrointestinal diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with renal diseases admitted to neonatal intensive care units
all neonates admitted with renal diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with central nervous system diseases admitted to neonatal intensive care units
all neonates admitted with central nervous system diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with metabolic diseases admitted to neonatal intensive care units
all neonates admitted with metabolic diseases in neonatal intensive care units
Measured: 12 months
document the number, & outcome in neonates with endocrinal diseases admitted to neonatal intensive care units
all neonates admitted with endocrinal diseases in neonatal intensive care units
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (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 DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rofida Abdelsabor Abdelbasset, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809063
- Sponsor's protocol ID
- Soh-Med-23-03-15MS
- Status last verified
- Mar 2023
- First submitted
- 30 Mar 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Persson M, Shah PS, Rusconi F, Reichman B, Modi N, Kusuda S, Lehtonen L, Hakansson S, Yang J, Isayama T, Beltempo M, Lee S, Norman M; International Network for Evaluating Outcomes of Neonates. Association of Maternal Diabetes With Neonatal Outcomes of Very Preterm and Very Low-Birth-Weight Infants: An International Cohort Study. JAMA Pediatr. 2018 Sep 1;172(9):867-875. doi: 10.1001/jamapediatrics.2018.1811.
PubMed 29971428Mansoor KP, Ravikiran SR, Kulkarni V, Baliga K, Rao S, Bhat KG, Baliga BS, Kamath N. Modified Sick Neonatal Score (MSNS): A Novel Neonatal Disease Severity Scoring System for Resource-Limited Settings. Crit Care Res Pract. 2019 May 9;2019:9059073. doi: 10.1155/2019/9059073. eCollection 2019.
PubMed 31210987Dorling JS, Field DJ, Manktelow B. Neonatal disease severity scoring systems. Arch Dis Child Fetal Neonatal Ed. 2005 Jan;90(1):F11-6. doi: 10.1136/adc.2003.048488.
PubMed 15613564
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization, Risk Factors and Outcome of Neonates Admitted to Neonatal Intensive Care Units (NICU) at Sohag University Hospitals
- ClinicalTrials.gov ID
- NCT05809063
- Acronym / sponsor ID
- Soh-Med-23-03-15MS
- Conditions
- Neonatal Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 12 Apr 2023 (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.
The neonatal period considered the time from birth up to the first 28 days of life \& further classified into:
- Very early birth (birth to < 24 hours).
- Early birth (24 hours to < 7 days).
- Late or last neonatal period (7 days to 28 days).
It is characterized by the transition from extra uterine life and rapid growth and development. It is the common vulnerable time or period of human life as it accounts for more high mortalities and morbidities, however, most of them are preventable.
The pattern of neonatal disease is a useful indicator of the availability, utilization and effectiveness of maternal and child health care services.
It varies from place to place and from time to time even in the same locality. Information on admission and mortality patterns of hospitalized neonates should reflect the major causes of illnesses and standard of care provided to neonates in a particular locality.
To improve neonatal services with better overall outcomes and less sever morbidities early identification of the risk factors is paramount so that appropriate interventions can be directed towards the most prevalent and treatable neonatal illnesses. To achieve this goal, it is important to study the pattern of neonatal admissions
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| cardiovascular patients | – | Other: observationalneonates that have cardiovascular diseases |
| respiratory patients | – | Other: observationalneonates that have respiratory diseases |
| gastrointestinal diseases | – | Other: observationalneonates that havegastrointestinal diseases |
| renal patients | – | Other: observationalneonates that have renal diseases |
| central nervous system diseases | – | Other: observationalneonates that have central nervous system diseases |
| metabolic patients | – | Other: observationalneonates that have metabolic diseases |
| endocrinal patients | – | Other: observationalneonates that have endocrinal diseases |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.
Key inclusion criteria (1 listed)
- All neonates that will be admitted in Neonatal Intensive Care Units (NICU) including preterm, term and post term neonates.
Key exclusion criteria (4 listed)
- Failure to obtain consent.
- Neonates need preparation for advanced interventions not available in our unit like cardiac operations.
- Neonates require peritoneal dialysis.
- Traumatic injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observationaldocument the number , disease pattern\& outcome of neonates admitted to the neonatal intensive care units | Other | cardiovascular patients, central nervous system diseases, endocrinal patients, gastrointestinal diseases, metabolic patients, renal patients, respiratory patients |
Primary outcome
document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with respiratory diseases in neonatal intensive care units
document the number, & outcome in neonates with cardiovascular diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with cardiovascular diseases in neonatal intensive care units
document the number, & outcome in neonates with gastrointestinal diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with gastrointestinal diseases in neonatal intensive care units
document the number, & outcome in neonates with renal diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with renal diseases in neonatal intensive care units
document the number, & outcome in neonates with central nervous system diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with central nervous system diseases in neonatal intensive care units
document the number, & outcome in neonates with metabolic diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with metabolic diseases in neonatal intensive care units
document the number, & outcome in neonates with endocrinal diseases admitted to neonatal intensive care units
Time frame: 12 months
all neonates admitted with endocrinal diseases in neonatal intensive care units
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Background: PubMed 29971428Persson M, Shah PS, Rusconi F, Reichman B, Modi N, Kusuda S, Lehtonen L, Hakansson S, Yang J, Isayama T, Beltempo M, Lee S, Norman M; International Network for Evaluating Outcomes of Neonates. Association of Maternal Diabetes With Neonatal Outcomes of Very Preterm and Very Low-Birth-Weight Infants: An International Cohort Study. JAMA Pediatr. 2018 Sep 1;172(9):867-875. doi: 10.1001/jamapediatrics.2018.1811.
- Background: PubMed 31210987Mansoor KP, Ravikiran SR, Kulkarni V, Baliga K, Rao S, Bhat KG, Baliga BS, Kamath N. Modified Sick Neonatal Score (MSNS): A Novel Neonatal Disease Severity Scoring System for Resource-Limited Settings. Crit Care Res Pract. 2019 May 9;2019:9059073. doi: 10.1155/2019/9059073. eCollection 2019.
- Background: PubMed 15613564Dorling JS, Field DJ, Manktelow B. Neonatal disease severity scoring systems. Arch Dis Child Fetal Neonatal Ed. 2005 Jan;90(1):F11-6. doi: 10.1136/adc.2003.048488.
- Individual participant dataSharing planned: Undecided
Related trials for Neonatal Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
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.
Mohammed A Bakhet, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Diseases, run by Sohag University at 1 site in Egypt.
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 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 rofida A Mohamed, Resident (01032853330, rofidaabdelsabour@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
document the number, & outcome in neonates with respiratory diseases admitted to neonatal intensive care units (time frame: 12 months). The study lists 7 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 NCT05809063, 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 12 Apr 2023.