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Not yet recruiting NCT07188298

Risk Factors and Clinical Outcomes of Neonatal Anemia in NICU

Observational Hemolytic Disease of Newborn Anemia of Neonates Sepsis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Hemolytic Disease of Newborn, Anemia of Neonates, Sepsis. Basic parameters: 1 Day — 30 Days · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • Understanding the local prevalence, associated factors, and outcomes of neonatal anemia [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07188298 · neonatal anemia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗