Necrotizing Enterocolitis of NewbornNCT06632041
Necrotizing Enterocolities
An observational study of Necrotizing Enterocolitis of Newborn, run by Assiut University.
Trial summary
Haematological disturbances in neonates with necrotizing enterocolities Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Necrotizing Enterocolitis of Newborn
- What is being tested?
- Complete blood count
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Dec 2025
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with necrotizing enterocolities
Who may be able to join
- preterm less than 36 weeks
- Or very low birth weight less than 1500 gram
Who cannot join
- full term
- Normal birth weight ,Preterm with early breast feeding or more than 1500 gm
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: Haematological Disturbances in Neonates with Necrotizing Enterocolities
Haematological disturbances in neonates with necrotizing enterocolities
Read the detailed description
Necrotizing enterocolitis (NEC) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. With an incidence of about 7% in infants with BW \< 1500 g and mortality up to 30%, NEC presents as a medical and surgical emergency It is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. While exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis
- in this devastating disease with undetermined etiology. Breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in NEC
- The hematological abnormalities associated with NEC were first described 25 years ago by Hutter et al.The abnormalities observed in a series of 40 patients with NEC included thrombocytopenia, with
- and without disseminated intravascular coagulation (DIC), neutrophilia or neutropenia, and hemolytic anemia.
- Conditions
- Necrotizing Enterocolitis of Newborn
- Being tested
- Complete blood count
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complete blood countDiagnostic test
Study haemtological disturbances in neonates with necrotizing enterocolities
Complete blood countOther
Haemtological disturbances in neonates with necrotizing enterocolities
| Study group | Role | What they receive |
|---|---|---|
| Neonates with necrotizing enterocolities | Not described Receives: Diagnostic Test: Complete blood count; Other: Complete blood count |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim
:to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotizing Enterocolitis of NewbornStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat maher saad zakhary, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06632041
- Sponsor's protocol ID
- Necrotizing enterocolities
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haematological Disturbances in Neonates with Necrotizing Enterocolities
- ClinicalTrials.gov ID
- NCT06632041
- Acronym / sponsor ID
- Necrotizing enterocolities
- Conditions
- Necrotizing Enterocolitis of Newborn
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2024 (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.
Haematological disturbances in neonates with necrotizing enterocolities
Detailed description
Necrotizing enterocolitis (NEC) is an acquired, multifactorial and devastating gastrointestinal disease associated with high morbidity and mortality in preterm neonates. With an incidence of about 7% in infants with BW \< 1500 g and mortality up to 30%, NEC presents as a medical and surgical emergency It is characterized by ischemia, necrosis, and inflammation of bowel wall with invasion by gas-forming organisms and intramural dissection of gas ,characteristicall appearing as pneumatosis intestinalis in radiological and pathological studies. While exact etiology is undetermined, the pathogenesis is believed to be an anomalous innate immune response to an altered, less diverse intestinal microbiota by the highly immunoreactive enterocytes of premature infants, leading to inflammation and tissue necrosis
- in this devastating disease with undetermined etiology. Breast milk feeding, prolonging gestation to avoid prematurity, antenatal steroid, and the use of probiotics/prebiotics are established prevention strategies in NEC
- The hematological abnormalities associated with NEC were first described 25 years ago by Hutter et al.The abnormalities observed in a series of 40 patients with NEC included thrombocytopenia, with
- and without disseminated intravascular coagulation (DIC), neutrophilia or neutropenia, and hemolytic anemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates with necrotizing enterocolities | – | Diagnostic Test: Complete blood count, Other: Complete blood count |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with necrotizing enterocolities
Key inclusion criteria (2 listed)
- preterm less than 36 weeks
- Or very low birth weight less than 1500 gram
Key exclusion criteria (2 listed)
- full term
- Normal birth weight ,Preterm with early breast feeding or more than 1500 gm
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 |
|---|---|---|
| Complete blood countStudy haemtological disturbances in neonates with necrotizing enterocolities | Diagnostic test | Neonates with necrotizing enterocolities |
| Complete blood countHaemtological disturbances in neonates with necrotizing enterocolities | Other | Neonates with necrotizing enterocolities |
Primary outcome
Aim
Time frame: Baseline
:to delineate haemtological abnormalities in neonatal necrotizing enterocolities as predictors of morbidity and mortality
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 10 Oct 2024.
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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 Necrotizing Enterocolitis of Newborn, 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 2 inclusion and 2 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 10 Oct 2024. 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 Mervat Maher Zakhary (01026767826, mahersaaad56@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2024.