Intraventricular Hemorrhage of PrematurityNCT07198360
Outcome of Intraventricular Hemorrhage in Preterm Infants
An observational study of Intraventricular Hemorrhage of Prematurity, run by Assiut University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Intraventricular Hemorrhage of Prematurity
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 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 Up to 28 days
- All sexes
- Child
Study population: All with the required Criteria
Who may be able to join
- Preterm neonates < 34 weeks of gestation
- Birth weight < 1500g
- Admitted to NICU within 24 hours of birth
Who cannot join
- Major congenital malformations (especially CNS anomalies)
- Severe perinatal asphyxia
- Neonates with congenital infections (TORCH)
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: Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU
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).
Read the detailed description
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 .
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Not found
What is being measured
The primary outcome is the main question the study is designed to answer.
. 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.
Outcome of intraventricular haemorrhage in preterm infants
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraventricular Hemorrhage of PrematurityStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Romany Nady Isaac Ayad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198360
- Sponsor's protocol ID
- IVH in preterm infants
- Status last verified
- Sep 2025
- First submitted
- 14 Sep 2025
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Parodi A, Govaert P, Horsch S, Bravo MC, Ramenghi LA; eurUS.brain group. Cranial ultrasound findings in preterm germinal matrix haemorrhage, sequelae and outcome. Pediatr Res. 2020 Mar;87(Suppl 1):13-24. doi: 10.1038/s41390-020-0780-2.
PubMed 32218535Kolnik SE, Upadhyay K, Wood TR, Juul SE, Valentine GC. Reducing Severe Intraventricular Hemorrhage in Preterm Infants With Improved Care Bundle Adherence. Pediatrics. 2023 Sep 1;152(3):e2021056104. doi: 10.1542/peds.2021-056104.
PubMed 37609772Legge N, Lutz T, Wocadlo C, Rieger I. Long-term neurodevelopmental outcome in preterm infants with intraventricular haemorrhage. J Paediatr Child Health. 2022 Oct;58(10):1797-1802. doi: 10.1111/jpc.16108. Epub 2022 Jul 15.
PubMed 35837759
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Risk Factors, and Outcomes of Intraventricular Hemorrhage in Preterm Infants Admitted to the NICU
- ClinicalTrials.gov ID
- NCT07198360
- Acronym / sponsor ID
- IVH in preterm infants
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 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.
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).
Detailed description
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 .
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- All with the required Criteria
Key inclusion criteria (3 listed)
- Preterm neonates < 34 weeks of gestation
- Birth weight < 1500g
- Admitted to NICU within 24 hours of birth
Key exclusion criteria (3 listed)
- Major congenital malformations (especially CNS anomalies)
- Severe perinatal asphyxia
- Neonates with congenital infections (TORCH)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNot found | Other | – |
Primary outcome
. 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
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 30 Sep 2025.
- Background: PubMed 32218535Parodi A, Govaert P, Horsch S, Bravo MC, Ramenghi LA; eurUS.brain group. Cranial ultrasound findings in preterm germinal matrix haemorrhage, sequelae and outcome. Pediatr Res. 2020 Mar;87(Suppl 1):13-24. doi: 10.1038/s41390-020-0780-2.
- Background: PubMed 37609772Kolnik SE, Upadhyay K, Wood TR, Juul SE, Valentine GC. Reducing Severe Intraventricular Hemorrhage in Preterm Infants With Improved Care Bundle Adherence. Pediatrics. 2023 Sep 1;152(3):e2021056104. doi: 10.1542/peds.2021-056104.
- Background: PubMed 35837759Legge N, Lutz T, Wocadlo C, Rieger I. Long-term neurodevelopmental outcome in preterm infants with intraventricular haemorrhage. J Paediatr Child Health. 2022 Oct;58(10):1797-1802. doi: 10.1111/jpc.16108. Epub 2022 Jul 15.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraventricular Hemorrhage of Prematurity, 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 3 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 30 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 Romany Nady Isaac Ayad (01142602768, romanynady2223@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
. 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198360, which also lists 3 linked publications.
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 30 Sep 2025.