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NCT Number: NCT07198360

Outcome of Intraventricular Hemorrhage in Preterm Infants

To determine the incidence and grading of IVH among preterm neonates in the NICU.

* To identify maternal and neonatal risk factors associated with IVH. * To assess short-term outcomes (mortality, Hydrocephalus, need for neurosurgical intervention, seizures, length of Hospital stay).

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Key information

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Observational

About this study

Intraventricular hemorrhage (IVH) is described as bleeding that occurs within and surrounding the brain ventricles, which contain cerebrospinal fluid . IVH is one of the most severe complications affecting preterm newborns globally, frequently leading to poor prognoses and potential mortality due to both short- and long-term neurodevelopmental consequences. The risk is markedly elevated for preterm newborns with a short gestational age, as roughly 15-20% of those born prior to 32 weeks of gestation are at the greatest risk of suffering a severe form of intraventricular hemorrhage . In term newborns, IVH occurs with an incidence of 5.5%, primarily due to perinatal head trauma, birth hypoxia, or coagulation disorders .

The IVH is diagnosed using cranial ultrasound (CUS), which is performed within the first 72 hours of life and repeated as clinically indicated. The IVH grade will be classified according to the Papile classification, which includes Grades I, II, III, and IV . Grades I and II were classified as mild intraventricular hemorrhage (IVH), whereas grades III and IV were classified as severe IVH. Grade IV IVH is now designated as periventricular hemorrhage infarction or parenchymal hemorrhage in recent years .

The risk factors for IVH include acute placental inflammation, elevated leukocyte count within the first 72 hours post-birth, increased white blood cell levels, and male sex. Additional risk factors for IVH encompass prematurity, low birthweight (LBW), prolonged mechanical ventilation, a low 5-minute Apgar score, hypoxia-related injury, hypothermic ischemia, pneumothorax, thrombocytopenia, antenatal maternal hemorrhage, maternal infection or inflammation, sepsis, hypotension, hypoxia, hypercapnia, seizures, patent ductus arteriosus (PDA), infection, respiratory distress, and genetic predispositions .

IVH in neonates, particularly preterm infants, often presents with nonspecific clinical signs such as apnea, bradycardia, hypotonia, bulging fontanelle, seizures, or a sudden drop in hematocrit. Some cases may be clinically silent, making routine screening essential . The diagnosis is primarily made using transcranial ultrasound (cranial sonography), which is a non-invasive, bedside imaging tool capable of detecting IVH grades, ventricular dilation, and parenchymal involvement through the anterior fontanelle. Outcomes vary depending on the severity (graded IIV), with lower grades (III) often resolving without long-term consequences, while higher grades (IIIIV) are associated with complications such as post-hemorrhagic hydrocephalus, cerebral palsy, developmental delay, and increased mortality. Early detection through serial ultrasound monitoring plays a critical role in management and prognosis .

Who can participate

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

Inclusion criteria

  • Preterm neonates < 34 weeks of gestation
  • Birth weight < 1500g
  • Admitted to NICU within 24 hours of birth

Exclusion criteria

  • Major congenital malformations (especially CNS anomalies)
  • Severe perinatal asphyxia
  • Neonates with congenital infections (TORCH)

Treatment and study plan

No intervention

Other

Not found

Primary outcomes

  1. . To determine the incidence of IVH in preterm infants within the first 7 days of life using cranial ultrasound. . To assess the grade of IVH (Papile classification I-IV) in preterm infants based on cranial US findings.

    Time frame: Baseline

    Outcome of intraventricular haemorrhage in preterm infants

Study contacts

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

Romany Nady Isaac Ayad

CONTACT

[email protected]

01142602768

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Sep 30, 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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