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NCT Number: NCT07188298

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Harris

CONTACT

[email protected]

+201061020985

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 23, 2025
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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