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Outcomes of Neonatal Resuscitation

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ClinicalTrials.gov Identifier: NCT02840682
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : October 6, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Actual Enrollment : 15073 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Outcomes of Neonatal Resuscitation in a Resource Limited Setting on the Thailand-Myanmar Border
Actual Study Start Date : April 2016
Actual Primary Completion Date : August 15, 2016
Actual Study Completion Date : August 15, 2016



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840682


Locations
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Thailand
Shoklo Malaria Research Unit
Mae Sot, Tak, Thailand, 63110
Sponsors and Collaborators
University of Oxford
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02840682    
Other Study ID Numbers: SMRU1603
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by University of Oxford:
resource limited setting
Thailand-Myanmar border