Neonatal ResuscitationNCT02840682
Outcomes of Neonatal Resuscitation
An observational study of Neonatal Resuscitation, run by University of Oxford at 1 site in Thailand.
Trial summary
The primary objective of this study is to describe mortality of newborns who received basic, advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research Unit. Read more about this study
- Who is it for?
- Ages Up to 28 weeksHealthy volunteers can take part
- Conditions the study is for
- Neonatal Resuscitation
- How many people
- 15,073 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2016to 15 Aug 2016
- Phase
- Observational
- 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 Up to 28 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: All liveborn, singletons, ≥28 weeks gestation, birthed at SMRU, from 1 January 2008 to 31 December 2015 will be included.
Who may be able to join
- Liveborn singletons birthed at SMRU
- ≥28 weeks gestation
Who cannot join
- Stillborn infants
- Liveborn infants birthed at home or in the Thai hospital
- Major congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Neonatal Resuscitation in a Resource Limited Setting on the Thailand-Myanmar Border
The primary objective of this study is to describe mortality of newborns who received basic, advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research Unit.
Read the detailed description
This is a retrospective, descriptive study of hospital records will be conducted. The existing dataset of newborns of ≥28 weeks gestation delivered at Shoklo Malaria Research Unit clinics from January 2008 to December 2015 will be analysed.
In the dataset, 15224 newborns fulfill the inclusion criteria and therefore they will all be analysed with IBM SPSS Statistics 22 for Windows.
Descriptive statistics will be used to define: a) the proportion of newborns alive at 24 hours, 7 days, 28 days, and at 1 year, following resuscitation at SMRU birthing rooms and b) the number of newborns requiring basic and advanced resuscitation.
Measurements of correlation coefficient will be used to compare Shoklo Developmental test scores and developmental milestones attained at 1 year in resuscitated and non-resuscitated infants. The Pearson correlation coefficient will be used if the relationship between two variables is found to be linear.
Antenatal, perinatal and postnatal characteristics associated with neonatal resuscitation will be defined by logistic regression analysis.
- Conditions
- Neonatal Resuscitation
- Keywords
- resource limited setting, Thailand-Myanmar border
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality 24 hours after birth of babies who received basic resuscitation
Measured: 24 hours
Mortality 24 hours after birth of babies who received advanced resuscitation
Measured: 24 hours
Mortality 24 hours after birth of babies who did not receive neonatal resuscitation
Measured: 24 hours
Secondary outcomes (11)
Mortality at 7 days
Measured: 7 days
Mortality at 28 days
Measured: 28 days
Mortality at one year
Measured: 1 year
Proportion of live births requiring basic or advanced neonatal resuscitation.
Measured: 24 hours
Number of newborns who received basic resuscitation, as a proportion of all live births.
Measured: 24 hours
Number of newborns who received advance resuscitation, as a proportion of all live births.
Measured: 24 hours
Shoklo Developmental test scores at 1 year in infants who received basic or advanced neonatal resuscitation or no resuscitation.
Measured: up to 1 year of age
Month of achieved milestones (crawl, walk, talk) in in infants who received basic or advanced neonatal resuscitation or no resuscitation.
Measured: up to 1 year of age
characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Measured: 24 hours
characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Measured: 24 hours
characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study startApr 2016
- Primary completion15 Aug 2016
- Study completion15 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 15,073 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02840682
- Sponsor's protocol ID
- SMRU1603
- Status last verified
- Oct 2017
- First submitted
- 7 Jun 2016
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Neonatal Resuscitation in a Resource Limited Setting on the Thailand-Myanmar Border
- ClinicalTrials.gov ID
- NCT02840682
- Acronym / sponsor ID
- SMRU1603
- Conditions
- Neonatal Resuscitation
- Keywords
- resource limited setting, Thailand-Myanmar border
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,073 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 15 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 21 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.
The primary objective of this study is to describe mortality of newborns who received basic, advanced or no neonatal resuscitation immediately after birth at Shoklo Malaria Research Unit.
Detailed description
This is a retrospective, descriptive study of hospital records will be conducted. The existing dataset of newborns of ≥28 weeks gestation delivered at Shoklo Malaria Research Unit clinics from January 2008 to December 2015 will be analysed.
In the dataset, 15224 newborns fulfill the inclusion criteria and therefore they will all be analysed with IBM SPSS Statistics 22 for Windows.
Descriptive statistics will be used to define: a) the proportion of newborns alive at 24 hours, 7 days, 28 days, and at 1 year, following resuscitation at SMRU birthing rooms and b) the number of newborns requiring basic and advanced resuscitation.
Measurements of correlation coefficient will be used to compare Shoklo Developmental test scores and developmental milestones attained at 1 year in resuscitated and non-resuscitated infants. The Pearson correlation coefficient will be used if the relationship between two variables is found to be linear.
Antenatal, perinatal and postnatal characteristics associated with neonatal resuscitation will be defined by logistic regression analysis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 28 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All liveborn, singletons, ≥28 weeks gestation, birthed at SMRU, from 1 January 2008 to 31 December 2015 will be included.
Key inclusion criteria (2 listed)
- Liveborn singletons birthed at SMRU
- ≥28 weeks gestation
Key exclusion criteria (3 listed)
- Stillborn infants
- Liveborn infants birthed at home or in the Thai hospital
- Major congenital abnormalities
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
Mortality 24 hours after birth of babies who received basic resuscitation
Time frame: 24 hours
Mortality 24 hours after birth of babies who received advanced resuscitation
Time frame: 24 hours
Mortality 24 hours after birth of babies who did not receive neonatal resuscitation
Time frame: 24 hours
11 secondary outcomes
Mortality at 7 days
Time frame: 7 days
Mortality at 28 days
Time frame: 28 days
Mortality at one year
Time frame: 1 year
Proportion of live births requiring basic or advanced neonatal resuscitation.
Time frame: 24 hours
Number of newborns who received basic resuscitation, as a proportion of all live births.
Time frame: 24 hours
Number of newborns who received advance resuscitation, as a proportion of all live births.
Time frame: 24 hours
Shoklo Developmental test scores at 1 year in infants who received basic or advanced neonatal resuscitation or no resuscitation.
Time frame: up to 1 year of age
Month of achieved milestones (crawl, walk, talk) in in infants who received basic or advanced neonatal resuscitation or no resuscitation.
Time frame: up to 1 year of age
characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Time frame: 24 hours
characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Time frame: 24 hours
characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
Time frame: 24 hours
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 6 Oct 2017.
- Individual participant dataSharing planned: Yes
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Enrolling by invitation
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Recruiting
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Active, not recruiting
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Neonatal Resuscitation, run by University of Oxford at 1 site in Thailand.
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 3 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 6 Oct 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 Thailand. 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?
Mortality 24 hours after birth of babies who received basic resuscitation (time frame: 24 hours). The study lists 3 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 6 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.