Neonatal HypoglycemiaPhase 3NCT02838875
To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
A Phase 3 study testing Blood samples in people with Neonatal Hypoglycemia, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neonatal Hypoglycemia
- What is being tested?
- Blood samples
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single pregnancy
- Vaginal or cesarean birth.
- Births where there is an indication of neonatal hypoglycemia follow-up - one or more of the following:
- Delivery week below 37 full weeks.
- Maternal diabetes during pregnancy (gestational diabetes or pre-gestational).
- Newborn under percentile 10 by Dolberg graph.
- Newborn above percentile 90 by Dolberg graph.
Who cannot join
- Multiple Pregnancy
- pregnancies in which there is no indication for routine monitoring of glucose levels after birth
Trial locations and contacts
No sites are listed yet.
About this study
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
Read the detailed description
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
PATIENTS \& METHODS All women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because his affiliation to the at-risk population including: delivery below 37th week, maternal diabetes during pregnancy and newborns in weight under percentile 10 or above percentile 90 by Dolberg graphs.
- Conditions
- Neonatal Hypoglycemia
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
After birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women at risk population | Experimental | women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because of their affiliation to the at-risk population. Receives: Procedure: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Taking blood samples as a predictor to number of Hypoglycemic children.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yariv Yogev, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838875
- Sponsor's protocol ID
- 0253-16-TLV
- Status last verified
- Jul 2016
- First submitted
- 18 Jul 2016
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
- ClinicalTrials.gov ID
- NCT02838875
- Acronym / sponsor ID
- 0253-16-TLV
- Conditions
- Neonatal Hypoglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2016
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 20 Jul 2016 (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.
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
Detailed description
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
PATIENTS \& METHODS All women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because his affiliation to the at-risk population including: delivery below 37th week, maternal diabetes during pregnancy and newborns in weight under percentile 10 or above percentile 90 by Dolberg graphs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women at risk population | Experimental | Procedure: Blood sampleswomen who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because of their affiliation to the at-risk population. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Single pregnancy
- Vaginal or cesarean birth.
- Births where there is an indication of neonatal hypoglycemia follow-up - one or more of the following:
Key exclusion criteria (2 listed)
- Multiple Pregnancy
- pregnancies in which there is no indication for routine monitoring of glucose levels 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesAfter birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient. | Procedure or surgery | Pregnant women at risk population |
Primary outcome
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Time frame: 2 weeks
Taking blood samples as a predictor to number of Hypoglycemic children.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- 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. This study is not recruiting at the moment.
Yariv Yogev, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood samples in people with Neonatal Hypoglycemia, run by Tel-Aviv Sourasky Medical Center.
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 7 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: status not confirmed, as of the sponsor's last update on 20 Jul 2016. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yariv Yogev, professor (052-7360616, yarivy@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cord blood glucose levels as a predictor to newborns Hypoglycemia (time frame: 2 weeks). 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 20 Jul 2016.