Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00136708
Status:
COMPLETED
Last Update Posted:
2014-07-31
First Post:
2005-08-25
Brief Title:
First Breath Neonatal Resuscitation in Developing Countries
Sponsor:
NICHD Global Network for Womens and Childrens Health
Organization:
NICHD Global Network for Womens and Childrens Health
Study Overview
Official Title:
FIRST BREATH Neonatal Resuscitation in Developing Countries
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:
In developing countries neonatal death from birth asphyxia is a major problem This study will be conducted in several countries 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 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 The primary hypothesis of this randomized controlled trial 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
The study design will include education and training of personnel at the community level and implementation of an NRP intervention to assure validity accuracy and precision of the estimate of the treatment effects The primary hypothesis is that implementation of the NRP educational programs will result in a decrease in neonatal mortality The primary outcome will be a decrease in all cause early 7 day neonatal mortality mortality due to any cause in the NRP trained communities when compared to the non-NRP trained communities Secondary outcomes will include early 7 day neonatal mortality associated with perinatal asphyxia mortality or hypoxic ischemic encephalopathy HIE at 7 days need for advanced resuscitation and Apgar scores at 5 minutes as well as providers self-efficacy knowledge competence and performance in neonatal resuscitation
This cluster randomized trial will be performed in communities of the Global Network GN sites One half of the communities will be randomized to Early Training and Intervention with NRP the other half will be randomized to Late Training and Intervention Data collection will be obtained at baseline for both groups in order to establish baseline data including neonatal mortality and asphyxia Following the baseline data collection period training of the health care providers with the WHO Integrated Management of Pregnancy and Childbirth Pregnancy Postpartum and Newborn Care Guide for Essential Practice 2003 Essential Newborn Care Program ENC will be performed using a train-the-trainer system Following this training communities will be randomized to Early or Late Training and Intervention with ENC Initially the Early Training and Intervention sites will have a program of train-the-trainers in NRP Following a 12-month period of intervention NRP vs control the providers of the Late Training and Intervention sites will have training in NRP
Based on the early first 7 days after birth neonatal mortality data collected in preparation for this protocol we estimate that there are 25 neonatal deaths1000 live births The trial is designed to identify a relative risk reduction of at least 20 absolute risk reduction of 5 or 51000 live births from 251000 to 201000 live births in the treatment group as compared to the control group The sample size necessary for the 20 relative risk reduction will be at least 32 communities with an average number of births of 500 per year however we plan to randomize at least 40 communities to account for potential drop-out The proposed enrollment period for the randomized intervention will last one year
The study design will include education and training of personnel at the community level and implementation of an NRP intervention to assure validity accuracy and precision of the estimate of the treatment effects The primary hypothesis is that implementation of the NRP educational programs will result in a decrease in neonatal mortality The primary outcome will be a decrease in all cause early 7 day neonatal mortality mortality due to any cause in the NRP trained communities when compared to the non-NRP trained communities Secondary outcomes will include early 7 day neonatal mortality associated with perinatal asphyxia mortality or hypoxic ischemic encephalopathy HIE at 7 days need for advanced resuscitation and Apgar scores at 5 minutes as well as providers self-efficacy knowledge competence and performance in neonatal resuscitation
This cluster randomized trial will be performed in communities of the Global Network GN sites One half of the communities will be randomized to Early Training and Intervention with NRP the other half will be randomized to Late Training and Intervention Data collection will be obtained at baseline for both groups in order to establish baseline data including neonatal mortality and asphyxia Following the baseline data collection period training of the health care providers with the WHO Integrated Management of Pregnancy and Childbirth Pregnancy Postpartum and Newborn Care Guide for Essential Practice 2003 Essential Newborn Care Program ENC will be performed using a train-the-trainer system Following this training communities will be randomized to Early or Late Training and Intervention with ENC Initially the Early Training and Intervention sites will have a program of train-the-trainers in NRP Following a 12-month period of intervention NRP vs control the providers of the Late Training and Intervention sites will have training in NRP
Based on the early first 7 days after birth neonatal mortality data collected in preparation for this protocol we estimate that there are 25 neonatal deaths1000 live births The trial is designed to identify a relative risk reduction of at least 20 absolute risk reduction of 5 or 51000 live births from 251000 to 201000 live births in the treatment group as compared to the control group The sample size necessary for the 20 relative risk reduction will be at least 32 communities with an average number of births of 500 per year however we plan to randomize at least 40 communities to account for potential drop-out The proposed enrollment period for the randomized intervention will last one year
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