Hemolytic Disease of NewbornNCT07188298
Risk Factors and Clinical Outcomes of Neonatal Anemia in NICU
An observational study of Hemolytic Disease of Newborn and Anemia of Neonates, run by Assiut University.
Trial summary
Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital Read more about this study
- Who is it for?
- Ages 1 day to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Hemolytic Disease of Newborn, Anemia of Neonates, Sepsis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 25 Oct 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: neonates
Who may be able to join
- All live-born neonates admitted to the NICU within the first 24 hours of life.
- Both term and preterm infants.
Who cannot join
- Major congenital malformations
- Chromosomal abnormalities or genetic syndromes
- Neonates with a previous blood transfusion before study enrollment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital
Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital
Read the detailed description
Neonatal anemia is one of the most common hematological problems encountered in neonatal intensive care units (NICUs), particularly among preterm and very low birth-weight (VLBW) infants. It is defined as a hemoglobin (Hb) or hematocrit (Hct) concentration below the normal range for gestational and postnatal age, often necessitating clinical intervention to ensure adequate tissue oxygenation and prevent long-term neurodevelopmental consequences Anemia: Hb <13 g/dL in term newborns; Hb <12 g/dL in preterm neonates within the first week of life, according to WHO criteria The pathophysiology is multifactorial, involving both physiological and pathological processes. In preterm neonates, the condition known as anemia of prematurity (AOP) is primarily characterized by reduced erythropoietin production, shortened red blood cell (RBC) lifespan, and rapid postnatal growth that increases iron demand Globally, over 80% of extremely preterm infants (<28 weeks of gestation) require at least one RBC transfusion during their hospitalization . In Egypt, recent tertiary-level NICU data suggest that the prevalence of neonatal anemia among admitted preterm infants exceeds 60%, with many requiring multiple transfusions in the first month of life Major contributing factors include iatrogenic blood loss from frequent phlebotomy, insufficient iron stores at birth due to shortened gestation, hemolysis (immune or non-immune), and acute blood loss from perinatal events
- Conditions
- Hemolytic Disease of Newborn, Anemia of Neonates, Sepsis
- Medical subject headings
- Erythroblastosis, Fetal, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding the local prevalence, associated factors, and outcomes of neonatal anemia
To determine the prevalence of neonatal anemia among neonates admitted to a tertiary care neonatal intensive care unit (NICU
- To identify maternal, perinatal, and neonatal risk factors associated with neonatal anemia
- To assess short-term outcomes, including length of hospital stay, need for blood transfusion, morbidity, and mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start25 Oct 2025 (estimated)
- Primary completion25 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemolytic Disease of NewbornStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Harris Ali, Assiut University
- Investigators
- safwat abdelaziz, Study director, Assiut Universitym hamdy ghazaly, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188298
- Sponsor's protocol ID
- neonatal anemia
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital
- ClinicalTrials.gov ID
- NCT07188298
- Acronym / sponsor ID
- neonatal anemia
- Conditions
- Hemolytic Disease of Newborn, Anemia of Neonates, Sepsis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 25 Oct 2025 (estimated)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 23 Sep 2025 (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.
Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital
Detailed description
Neonatal anemia is one of the most common hematological problems encountered in neonatal intensive care units (NICUs), particularly among preterm and very low birth-weight (VLBW) infants. It is defined as a hemoglobin (Hb) or hematocrit (Hct) concentration below the normal range for gestational and postnatal age, often necessitating clinical intervention to ensure adequate tissue oxygenation and prevent long-term neurodevelopmental consequences Anemia: Hb <13 g/dL in term newborns; Hb <12 g/dL in preterm neonates within the first week of life, according to WHO criteria The pathophysiology is multifactorial, involving both physiological and pathological processes. In preterm neonates, the condition known as anemia of prematurity (AOP) is primarily characterized by reduced erythropoietin production, shortened red blood cell (RBC) lifespan, and rapid postnatal growth that increases iron demand Globally, over 80% of extremely preterm infants (<28 weeks of gestation) require at least one RBC transfusion during their hospitalization . In Egypt, recent tertiary-level NICU data suggest that the prevalence of neonatal anemia among admitted preterm infants exceeds 60%, with many requiring multiple transfusions in the first month of life Major contributing factors include iatrogenic blood loss from frequent phlebotomy, insufficient iron stores at birth due to shortened gestation, hemolysis (immune or non-immune), and acute blood loss from perinatal events
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
- neonates
Key inclusion criteria (2 listed)
- All live-born neonates admitted to the NICU within the first 24 hours of life.
- Both term and preterm infants.
Key exclusion criteria (3 listed)
- Major congenital malformations
- Chromosomal abnormalities or genetic syndromes
- Neonates with a previous blood transfusion before study enrollment
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
Understanding the local prevalence, associated factors, and outcomes of neonatal anemia
Time frame: 1 year
To determine the prevalence of neonatal anemia among neonates admitted to a tertiary care neonatal intensive care unit (NICU * To identify maternal, perinatal, and neonatal risk factors associated with neonatal anemia * To assess short-term outcomes, including length of hospital stay, need for blood transfusion, morbidity, and mortality
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
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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.
safwat abdelaziz study director
Assiut University
m hamdy ghazaly study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Hemolytic Disease of Newborn and Anemia of Neonates, 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 3 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: opening soon, as of the sponsor's last update on 23 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Harris (+201061020985, saleh111.osman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Understanding the local prevalence, associated factors, and outcomes of neonatal anemia (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2025.