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Clinical Trials/NCT02840682
NCT02840682
Completed
Not Applicable

Outcomes of Neonatal Resuscitation in a Resource Limited Setting on the Thailand-Myanmar Border

University of Oxford1 site in 1 country15,073 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Resuscitation
Sponsor
University of Oxford
Enrollment
15073
Locations
1
Primary Endpoint
Mortality 24 hours after birth of babies who did not receive neonatal resuscitation
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
August 15, 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Liveborn singletons birthed at SMRU
  • ≥28 weeks gestation

Exclusion Criteria

  • Stillborn infants
  • Liveborn infants birthed at home or in the Thai hospital
  • Major congenital abnormalities

Outcomes

Primary Outcomes

Mortality 24 hours after birth of babies who did not receive neonatal resuscitation

Time Frame: 24 hours

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

Secondary Outcomes

  • Mortality at 7 days(7 days)
  • Mortality at 28 days(28 days)
  • Mortality at one year(1 year)
  • Proportion of live births requiring basic or advanced neonatal resuscitation.(24 hours)
  • Number of newborns who received basic resuscitation, as a proportion of all live births.(24 hours)
  • Number of newborns who received advance resuscitation, as a proportion of all live births.(24 hours)
  • Shoklo Developmental test scores at 1 year in infants who received basic or advanced neonatal resuscitation or no resuscitation.(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.(up to 1 year of age)
  • characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter(24 hours)
  • characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter(24 hours)
  • characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter(24 hours)

Study Sites (1)

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