Clinical trial NCT02840682: Outcomes of Neonatal Resuscitation
Official title: Outcomes of Neonatal Resuscitation in a Resource Limited Setting on the Thailand-Myanmar Border
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Resuscitation
Keywords: resource limited setting
Thailand-Myanmar border
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 15073
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Mortality 24 hours after birth of babies who received basic resuscitation
timeFrame: 24 hours
measure: Mortality 24 hours after birth of babies who received advanced resuscitation
timeFrame: 24 hours
measure: Mortality 24 hours after birth of babies who did not receive neonatal resuscitation
timeFrame: 24 hours
Secondary outcomes:
measure: Mortality at 7 days
timeFrame: 7 days
measure: Mortality at 28 days
timeFrame: 28 days
measure: Mortality at one year
timeFrame: 1 year
measure: Proportion of live births requiring basic or advanced neonatal resuscitation.
timeFrame: 24 hours
measure: Number of newborns who received basic resuscitation, as a proportion of all live births.
timeFrame: 24 hours
measure: Number of newborns who received advance resuscitation, as a proportion of all live births.
timeFrame: 24 hours
measure: Shoklo Developmental test scores at 1 year in infants who received basic or advanced neonatal resuscitation or no resuscitation.
timeFrame: up to 1 year of age
measure: Month of achieved milestones (crawl, walk, talk) in in infants who received basic or advanced neonatal resuscitation or no resuscitation.
timeFrame: up to 1 year of age
measure: characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
timeFrame: 24 hours
measure: characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
timeFrame: 24 hours
measure: characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter
timeFrame: 24 hours
Other outcomes:
Locations:
city: Mae Sot
country: Thailand
facility: Shoklo Malaria Research Unit
state: Tak
Study officials:
References: