Outcomes of Neonatal Resuscitation

Neonatal Resuscitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02840682
• Other study ID #: SMRU1603
• Status: Completed
• Phase: N/A
• First received: June 7, 2016
• Last updated: October 5, 2017
• Start date: April 2016
• Est. completion date: August 15, 2016

Study information

• Verified date: October 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15073
• Est. completion date: August 15, 2016
• Est. primary completion date: August 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 28 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Neonatal Resuscitation

Locations

Country	Name	City	State
Thailand	Shoklo Malaria Research Unit	Mae Sot	Tak

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality 24 hours after birth of babies who received basic resuscitation		24 hours
Primary	Mortality 24 hours after birth of babies who received advanced resuscitation		24 hours
Primary	Mortality 24 hours after birth of babies who did not receive neonatal resuscitation		24 hours
Secondary	Mortality at 7 days		7 days
Secondary	Mortality at 28 days		28 days
Secondary	Mortality at one year		1 year
Secondary	Proportion of live births requiring basic or advanced neonatal resuscitation.		24 hours
Secondary	Number of newborns who received basic resuscitation, as a proportion of all live births.		24 hours
Secondary	Number of newborns who received advance resuscitation, as a proportion of all live births.		24 hours
Secondary	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
Secondary	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
Secondary	characteristics of antenatal infant receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter		24 hours
Secondary	characteristics of perinatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter		24 hours
Secondary	characteristics of neonatal infants receiving neonatal resuscitation compared to non-resuscitated infants as assessed by physiological parameter		24 hours