Status:
COMPLETED
Newborn Heart Rate as a Catalyst for Improved Survival
Lead Sponsor:
American Academy of Pediatrics
Collaborating Sponsors:
Kinshasa School of Public Health
Laerdal Global Health
Conditions:
Stillbirth
Neonatal Respiratory Depression
Eligibility:
All Genders
28-45 years
Brief Summary
Heart rate (HR) is not routinely assessed during newborn resuscitations in low- and lower-middle income countries (LMICs). Many non-breathing newborns classified as fresh stillbirths have a heartbeat ...
Eligibility Criteria
Inclusion
- all newborns delivered via vaginal, assisted or operative delivery at any of 3 participating maternity units in Kinshasa, Democratic Republic of Congo (DRC), during the study period will be enrolled. All newborns will be included, regardless of:
- intrauterine fetal demise
- birth weight
- congenital anomalies
- multiple gestation
- any maternal complication
Exclusion
- Newborns transferred to the maternity unit following delivery at a referral hospital or in the community
- Miscarriages, or previable newborns, defined as gestational age \<28 weeks (or if gestational age is unavailable, birth weight \<1,000g) at the time of delivery
Key Trial Info
Start Date :
July 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2020
Estimated Enrollment :
24034 Patients enrolled
Trial Details
Trial ID
NCT03799861
Start Date
July 5 2018
End Date
October 31 2020
Last Update
March 31 2022
Active Locations (3)
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1
Binza-Delvaux Maternity Hospital
Kinshasa, Democratic Republic of the Congo
2
Centre Hospital Kingasani
Kinshasa, Democratic Republic of the Congo
3
Mother and Child Hospital Bumbu
Kinshasa, Democratic Republic of the Congo