Outcomes of Neonatal Resuscitation

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Resuscitation

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 Type: Observational
• Enrollment (Actual): 15073

Contacts and Locations

Study Locations

• Thailand
  • Tak
    • Mae Sot, Tak, Thailand, 63110
      • Shoklo Malaria Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All liveborn, singletons, ≥28 weeks gestation, birthed at SMRU, from 1 January 2008 to 31 December 2015 will be included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Mortality 24 hours after birth of babies who did not receive neonatal resuscitation	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Oxford

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): August 15, 2016
• Study Completion (Actual): August 15, 2016

Study Registration Dates

• First Submitted: June 7, 2016
• First Submitted That Met QC Criteria: July 18, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2017
• Last Update Submitted That Met QC Criteria: October 5, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Thailand-Myanmar border; resource limited setting
• Other Study ID Numbers: SMRU1603

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes