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NCT Number: NCT02840682

Outcomes of Neonatal Resuscitation

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.

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Key information

Conditions

Neonatal Resuscitation

Age range

Up to 28 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality 24 hours after birth of babies who received basic resuscitation

    Time frame: 24 hours

  2. Mortality 24 hours after birth of babies who received advanced resuscitation

    Time frame: 24 hours

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

    Time frame: 24 hours

Secondary outcomes

  1. Mortality at 7 days

    Time frame: 7 days

  2. Mortality at 28 days

    Time frame: 28 days

  3. Mortality at one year

    Time frame: 1 year

  4. Proportion of live births requiring basic or advanced neonatal resuscitation.

    Time frame: 24 hours

  5. Number of newborns who received basic resuscitation, as a proportion of all live births.

    Time frame: 24 hours

  6. Number of newborns who received advance resuscitation, as a proportion of all live births.

    Time frame: 24 hours

  7. 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

  8. 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

  9. characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter

    Time frame: 24 hours

  10. characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter

    Time frame: 24 hours

  11. characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2016
Registry last updated
Oct 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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