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Outcomes of Neonatal Resuscitation

Sponsor
University of Oxford (Other)
Overall Status
Completed
CT.gov ID
NCT02840682
Collaborator
(none)
15,073
Enrollment
1
Location
4.5
Actual Duration (Months)
3373.4
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Apr 1, 2016
    Actual Primary Completion Date :
    Aug 15, 2016
    Actual Study Completion Date :
    Aug 15, 2016

    Outcome Measures

    Primary Outcome Measures

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

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

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

    Secondary Outcome Measures

    1. Mortality at 7 days [7 days]

    2. Mortality at 28 days [28 days]

    3. Mortality at one year [1 year]

    4. Proportion of live births requiring basic or advanced neonatal resuscitation. [24 hours]

    5. Number of newborns who received basic resuscitation, as a proportion of all live births. [24 hours]

    6. Number of newborns who received advance resuscitation, as a proportion of all live births. [24 hours]

    7. 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]

    8. 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]

    9. characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter [24 hours]

    10. characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter [24 hours]

    11. characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter [24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 28 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shoklo Malaria Research Unit Mae Sot Tak Thailand 63110

    Sponsors and Collaborators

    • University of Oxford

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Oxford
    ClinicalTrials.gov Identifier:
    NCT02840682
    Other Study ID Numbers:
    • SMRU1603
    First Posted:
    Jul 21, 2016
    Last Update Posted:
    Oct 6, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by University of Oxford
    resource limited setting
    Thailand-Myanmar border

    Study Results

    No Results Posted as of Oct 6, 2017