AsphyxiaNCT01305031
Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
A study testing Resuscitation and 100% oxygen in people with Asphyxia, run by Nanjing Medical University at 1 site in China.
Trial summary
In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects. Read more about this study
- Who is it for?
- Ages 34 to 37 weeks
- Conditions the study is for
- Asphyxia
- What is being tested?
- Resuscitation and 100% oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Feb 2011to Dec 2011
- 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 34 to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- inborn infant
- gestation 34 weeks to 36 weeks 6 days
Who cannot join
- known chromosomal or congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.
Read the detailed description
The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.
- Conditions
- Asphyxia
- Being tested
- Resuscitation, 100% oxygen
- Keywords
- Asphyxia, Resuscitation, Room Air
- Medical subject headings
- Asphyxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResuscitationOther
Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
100% oxygenOther
Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%
| Study group | Role | What they receive |
|---|---|---|
| Room air | Experimental | Initiation of resuscitation with 21% Oxygen, adjustments to the inspired oxygen concentration (increased 10%) will be made every 60 seconds for infants to achieve a target SpO2 range of 85-92% Receives: Other: Resuscitation |
| 100% Oxygen | Active comparator | Initiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92% Receives: Other: 100% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxidative stress status
Measured: 7 days
oxygen saturations
Measured: 10 min
Secondary outcomes (12)
Days on oxygen
Measured: 28 days
Days on conventional ventilation
Measured: 28 days
Days on high frequency ventilation
Measured: 28 days
Days on nasal canula
Measured: 28 days
Pneumothorax
Measured: 28 days
Oxygen requirement
Measured: At 36 weeks adjusted age
Patent ductus arteriosus
Measured: 28 days
Necrotizing Enterocolitis
Measured: 28 days
Intracranial hemorrhage
Measured: 28 days
Hypoxic ischemic encephalopathy
Measured: 28 days
Retinopathy of prematurity
Measured: 28 days
Death
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsphyxiaStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhangbin Yu, Nanjing Medical University
- Investigators
- Shuping Han, PhD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305031
- Sponsor's protocol ID
- NMU-FY2011-225, YKK10038
- Status last verified
- Oct 2014
- First submitted
- 25 Feb 2011
- Last updated
- 28 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitation of Late-preterm Infants by Using Room Air or 100% Oxygen
- ClinicalTrials.gov ID
- NCT01305031
- Acronym / sponsor ID
- NMU-FY2011-225, YKK10038
- Conditions
- Asphyxia
- Keywords
- Asphyxia, Resuscitation, Room Air
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Feb 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Feb 2011 (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.
In this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.
Detailed description
The delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. Some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. A static room air, however, may be inappropriate for resuscitation of preterm infants. The number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. Our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Room air | Experimental | Other: ResuscitationInitiation of resuscitation with 21% Oxygen, adjustments to the inspired oxygen concentration (increased 10%) will be made every 60 seconds for infants to achieve a target SpO2 range of 85-92% |
| 100% Oxygen | Active comparator | Other: 100% oxygenInitiation of resuscitation with 100% Oxygen and achieve oxygen saturation in the preset limits 85-92% |
Who may qualify
- Ages
- 34 to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- inborn infant
- gestation 34 weeks to 36 weeks 6 days
Key exclusion criteria (1 listed)
- known chromosomal or congenital anomalies
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 |
|---|---|---|
| ResuscitationUse of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92% | Other | Room air |
| 100% oxygenUse of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92% | Other | 100% Oxygen |
Primary outcome
oxidative stress status
Time frame: 7 days
oxygen saturations
Time frame: 10 min
12 secondary outcomes
Days on oxygen
Time frame: 28 days
Days on conventional ventilation
Time frame: 28 days
Days on high frequency ventilation
Time frame: 28 days
Days on nasal canula
Time frame: 28 days
Pneumothorax
Time frame: 28 days
Oxygen requirement
Time frame: At 36 weeks adjusted age
Patent ductus arteriosus
Time frame: 28 days
Necrotizing Enterocolitis
Time frame: 28 days
Intracranial hemorrhage
Time frame: 28 days
Hypoxic ischemic encephalopathy
Time frame: 28 days
Retinopathy of prematurity
Time frame: 28 days
Death
Time frame: 28 days
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 28 Oct 2014.
Related trials for Asphyxia
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.
Shuping Han, PhD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resuscitation and 100% oxygen in people with Asphyxia, run by Nanjing 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 2 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 28 Oct 2014. 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. 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?
oxidative stress status (time frame: 7 days). The study lists 2 primary outcomes in all. 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 28 Oct 2014.