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Risk Factors and Clinical Outcomes of Neonatal Anemia in NICU

Risk Factors, and Clinical Outcomes of Neonatal Anemia in the NICU of a Tertiary Care Hospital

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07188298
Enrollment
40
Registered
2025-09-23
Start date
2025-10-25
Completion date
2026-11-01
Last updated
2025-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia of Neonates, Hemolytic Disease of Newborn, Sepsis

Brief summary

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

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Days to 30 Days
Healthy volunteers
Yes

Inclusion criteria

* All live-born neonates admitted to the NICU within the first 24 hours of life. * Both term and preterm infants.

Exclusion criteria

* Major congenital malformations * Chromosomal abnormalities or genetic syndromes * Neonates with a previous blood transfusion before study enrollment

Design outcomes

Primary

MeasureTime frameDescription
Understanding the local prevalence, associated factors, and outcomes of neonatal anemia1 yearTo 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

Contacts

Primary ContactAli Harris
saleh111.osman@gmail.com+201061020985

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026