Outcomes of Neonatal Resuscitation

Completed

• Conditions: Neonatal Resuscitation

• Registration Number: NCT02840682
• Lead Sponsor: University of Oxford

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-07
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Primary Completion: 2016-08-15
• Study Completion: 2016-08-15
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-05
• Last Update Posted: 2017-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15073

Inclusion Criteria

• Liveborn singletons birthed at SMRU
• ≥28 weeks gestation

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality 24 hours after birth of babies who did not receive neonatal resuscitation	24 hours
Mortality 24 hours after birth of babies who received basic resuscitation	24 hours
Mortality 24 hours after birth of babies who received advanced resuscitation	24 hours

Secondary Outcome Measures

Name	Time	Method
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
Mortality at 7 days	7 days
Mortality at 28 days	28 days
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

Trial Locations

Locations (1)

Shoklo Malaria Research Unit; 🇹🇭 Mae Sot, Tak, Thailand