Asphyxia NeonatorumNCT01866358
Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
A study testing Intraosseous infusion and Umbilical vein infusion in people with Asphyxia Neonatorum, run by Third Military Medical University at 1 site in China.
Trial summary
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation Read more about this study
- Who is it for?
- Ages 28 to 42 weeks
- Conditions the study is for
- Asphyxia Neonatorum
- What is being tested?
- Intraosseous infusion and Umbilical vein infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- May 2013to May 2014
- Phase
- Interventional
- 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 28 to 42 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- newborns who need resucitation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
China1 site
Pediatrics of Daping Hospital
Chongqing, Chongqing Municipality, 400042
About this study
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation
- Conditions
- Asphyxia Neonatorum
- Being tested
- Intraosseous infusion, Umbilical vein infusion
- Medical subject headings
- Asphyxia Neonatorum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous infusionProcedure or surgery
Using intraosseous infusion for resustation in this group
Umbilical vein infusionProcedure or surgery
Using umbilical vein infusion for resustation in this group
| Study group | Role | What they receive |
|---|---|---|
| Umbilical vein infusion | Placebo comparator | using umbilical vein infusion for resucitation Receives: Procedure: Umbilical vein infusion |
| Intraosseous infusion | Experimental | using intraosseous infusion for resucitation Receives: Procedure: Intraosseous infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate of resuscitation
Measured: 24 hours
Secondary outcomes (1)
Injury of brain and heart
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asphyxia NeonatorumStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Military Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lixue, Third Military Medical University
- Investigators
- Shi Yuan, PhD, Study chair, Professor, Chief of Pediatric Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01866358
- Sponsor's protocol ID
- Wanglan
- Status last verified
- Jun 2018
- First submitted
- 21 May 2013
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous Infusion for Neonatal Asphyxiated Resuscitation
- ClinicalTrials.gov ID
- NCT01866358
- Acronym / sponsor ID
- Wanglan
- Conditions
- Asphyxia Neonatorum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Third Military Medical UniversityUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 31 May 2013 (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.
Intraosseous infusion is better than umbilical vein infusion for neonatal asphyxiated resuscitation
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical vein infusion | Placebo comparator | Procedure: Umbilical vein infusionusing umbilical vein infusion for resucitation |
| Intraosseous infusion | Experimental | Procedure: Intraosseous infusionusing intraosseous infusion for resucitation |
Who may qualify
- Ages
- 28 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- newborns who need resucitation
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Intraosseous infusionUsing intraosseous infusion for resustation in this group | Procedure or surgery | Intraosseous infusion |
| Umbilical vein infusionUsing umbilical vein infusion for resustation in this group | Procedure or surgery | Umbilical vein infusion |
Primary outcome
success rate of resuscitation
Time frame: 24 hours
1 secondary outcome
Injury of brain and heart
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
Related trials for Asphyxia Neonatorum
RecruitingPhase 2/3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia
Hypoxic-Ischemic Encephalopathy
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
Not yet recruiting
Levetiracetam as an Adjuvant Therapy to Hypothermia in Neonatal Asphyxia
Hypoxic Ischemic Encephalopathy of Newborn, Neuro-protection
Active, not recruiting
Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
IVH- Intraventricular Hemorrhage, Extreme Prematurity
Not yet recruiting
Magnesium Sulphate for Neonatal Asphyxia and Length of Hospital Stay
Duration of Hospitalization, Neonatal Mortality Rate
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.
Shi Yuan, PhD study chair
Professor, Chief of Pediatric Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraosseous infusion and Umbilical vein infusion in people with Asphyxia Neonatorum, run by Third Military Medical University at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 15 Jun 2018. 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 China. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate of resuscitation (time frame: 24 hours). 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 15 Jun 2018.