NCT02840682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,073

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

June 7, 2016

Last Update Submit

October 5, 2017

Conditions

Neonatal Resuscitation

Keywords

resource limited settingThailand-Myanmar border

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • 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

  • +6 more secondary outcomes

Eligibility Criteria

AgeUp to 28 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Liveborn singletons birthed at SMRU
  • ≥28 weeks gestation

You may not qualify if:

  • Stillborn infants
  • Liveborn infants birthed at home or in the Thai hospital
  • Major congenital abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shoklo Malaria Research Unit

Mae Sot, Changwat Tak, 63110, Thailand

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2016

First Posted

July 21, 2016

Study Start

April 1, 2016

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

October 6, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will share

Locations

TH(1)