Neonates PrematureNEONATAL ICHNCT03019692
Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage
An observational study of Neonates Premature, run by Laniado Hospital at 1 site in Israel.
Trial summary
Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Read more about this study
- Who is it for?
- Ages 1 hour to 3 months
- Conditions the study is for
- Neonates Premature
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2027
- 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 hour to 3 months
- All sexes
- No healthy volunteers
- Child
Study population: newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage within the first 3 months after birth or before discharge after delivery
Who may be able to join
- newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage children who are followed by PI in the neurosurgical clinic in Laniado hospital and suffered from ICH or IVH and were treated elsewhere after birth -
Who cannot join
- loss to followup within the first year after birth
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Sharon Nechama, Laniado Hospital
Netanya, Israel
Nechama Sharone, MD, 972-544303356, nsharon@laniado.org.il
Nechama Sharon, MD
About this study
Official title: Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to be associated with adverse neurodevelopmental outcomes.
However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm infants has not been well described.
Read more
Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is not well established.
The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and follow their radiological, cognitive, motor and functional outcomes.
The study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.
Read the detailed description
The study will be performed as a Retrospective chart review with key words : IVH, ICH of babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.
All charts of such children will be included, to review clinical, and radiological available data.
Registration of Clinical, Radiological data as presented or submitted by the parents on Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded in the data anonymously.
Follow up will be performed as clinically indicated without addition of any specific studies due to the research.
The endpoints of the study:
primary endpoint:
- How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
- Clinical and functional outcome of children - REGARDING normal schooling, need for assistance in ADL in difference from the parallel normal child. correlation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.
- Conditions
- Neonates Premature
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| enrolled babies with neonatal intracranial bleed | all babies who suffered from intra cranial or intraventricular bleed during neonatal period |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for surgery related to neonatal hemorrhage
Measured: 3 years
Secondary outcomes (2)
normal schooling according to age
Measured: 6 years
need for ADL assistance beyond acceptable per age
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates PrematureStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laniado Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laniado Hospital, Laniado Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019692
- Sponsor's protocol ID
- 0148-16-LND-2016121
- Acronym
- NEONATAL ICH
- Status last verified
- Jan 2017
- First submitted
- 11 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longterm Outcome of Children With Neonatal Intra-Ventricular or Intra-Cranial Hemorrhage (IVH, ICH)
- ClinicalTrials.gov ID
- NCT03019692
- Acronym / sponsor ID
- NEONATAL ICH / 0148-16-LND-2016121
- Conditions
- Neonates Premature
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Laniado HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- 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.
Intraventricular hemorrhage (IVH) is the most commonly recognized cerebral lesion on ultrasound in extremely preterm infants. Papile classification is commonly used to grade the severity of IVH. Grade III-IV IVH and other lesions noted on ultrasound including periventricular leukomalacia (pvl) porencephaly, and ventriculomegaly are well Documented to be associated with adverse neurodevelopmental outcomes.
However, the true impact of lower-grade IVH on the neurodevelopment of these extreme preterm infants has not been well described.
Also Neurodevelopmental outcome for neonatal non-traumatic Intra Cranial Hemorrhage (ICH) is not well established.
The aim of this study is to look retrospectively at babies with neonatal IVH or ICH and follow their radiological, cognitive, motor and functional outcomes.
The study will focus on postnatal files, and on images performed as part of the child's follow-up during hospitalization and after discharge.
Detailed description
The study will be performed as a Retrospective chart review with key words : IVH, ICH of babies discharged from Laniado Hospital Neonatal care service or ICU, or being followed in the pediatric neurosurgical clinic and prematurity/neonatology clinic of the hospital.
All charts of such children will be included, to review clinical, and radiological available data.
Registration of Clinical, Radiological data as presented or submitted by the parents on Neurosurgical neonatology and Neurological Followups will be performed by PI or CI and coded in the data anonymously.
Follow up will be performed as clinically indicated without addition of any specific studies due to the research.
The endpoints of the study:
primary endpoint:
- How many children needed surgical intervention related to the hemorrhage (ICH, IVH) secondary endpoints:
- Clinical and functional outcome of children - REGARDING normal schooling, need for assistance in ADL in difference from the parallel normal child. correlation between the type of hemorrhage, clinical data related to gestational age and weight at birth, and outcomes will be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| enrolled babies with neonatal intracranial bleed | – | –all babies who suffered from intra cranial or intraventricular bleed during neonatal period |
Who may qualify
- Ages
- 1 hour to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage within the first 3 months after birth or before discharge after delivery
Key inclusion criteria (1 listed)
- newborns or premature babies who suffered intra-cranial or intra-ventricular hemorrhage children who are followed by PI in the neurosurgical clinic in Laniado hospital and suffered from ICH or IVH and were treated elsewhere after birth -
Key exclusion criteria (2 listed)
- loss to followup within the first year after birth
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
need for surgery related to neonatal hemorrhage
Time frame: 3 years
2 secondary outcomes
normal schooling according to age
Time frame: 6 years
need for ADL assistance beyond acceptable per age
Time frame: 6 years
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 12 Jan 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonates Premature, run by Laniado Hospital at 1 site in Israel.
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 1 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: looking for participants now, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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 LIANA ADANI BENI, MD (97298609336, DRLIANA.PEDNS@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need for surgery related to neonatal hemorrhage (time frame: 3 years). 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 12 Jan 2017.