Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097097
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2004-11-17
Brief Title:
Neonatal Resuscitation in Zambia
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
Neonatal Resuscitation in Zambia
Status:
COMPLETED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Asphyxia is a leading cause of neonatal death in Zambia This study will be conducted in two cities in Zambia to determine if the combined Neonatal Resuscitation ProgramEssential Newborn Care Program compared to the new World Health Organization WHO basic perinatal care education of health care providers Essential Newborn Care Program results in reduced mortality due to perinatal asphyxia
Detailed Description:
Birth asphyxia defined as failure to initiate and sustain breathing at birth has been identified by the World Health Organization WHO as the most frequent cause of early deaths worldwide accounting for about 20 of neonatal mortality Although prompt resuscitation after birth can prevent many of the deaths and reduce disabilities in survivors from birth asphyxia the WHO has concluded that resuscitation is often not initiated or the methods used are inadequate or wrong The Neonatal Resuscitation Program NRP has been universally accepted in the developed world but has had limited dissemination in many developing countries including Zambia The primary hypothesis of this study is that implementation of the combined Neonatal Resuscitation ProgramWHO Essential Newborn Care ENC Program compared to basic neonatal care education of health care providers ENC only will result in reduced neonatal 7-day mortality This trial will be performed in two Zambian cities Lusaka and Ndola Training in data collection will be conducted in order to establish baseline data on mortality and asphyxia Following this time period all centers will receive the ENC training and continue to collect data for 7 months The clinics will then receive NRP Training and collect data for a 12-month period
The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period Secondary outcomes will include neonatal mortality due to perinatal asphyxia mortality or hypoxic ischemic encephalopathy HIE at 7 days need for advanced resuscitation Apgar scores at 5 minutes sustainability of the program as well as providers self efficacy competence and performance in neonatal resuscitation
The primary outcome will be a decrease in neonatal 7-day mortality following the NRP training when compared to the ENC-only time period Secondary outcomes will include neonatal mortality due to perinatal asphyxia mortality or hypoxic ischemic encephalopathy HIE at 7 days need for advanced resuscitation Apgar scores at 5 minutes sustainability of the program as well as providers self efficacy competence and performance in neonatal resuscitation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HD043464 | NIH | None | httpsreporternihgovquickSearchU01HD043464 |