An observational study in Neonatal Resuscitation, sponsored by University of Oxford. Completed at 1 site in Thailand. Open to participants aged Up to 28 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-06.
Sponsored by University of Oxford · Observational
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.
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.
University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All liveborn, singletons, ≥28 weeks gestation, birthed at SMRU, from 1 January 2008 to 31 December 2015 will be included.
Exclusion Criteria:
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
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
Plan to share: Yes
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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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