First Breath: Neonatal Resuscitation in Developing Countries
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00136708|
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 31, 2014
|Condition or disease||Intervention/treatment|
|Asphyxia Neonatorum||Procedure: Neonatal Resuscitation|
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 Program/WHO 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 deaths/1000 live births. The trial is designed to identify a relative risk reduction of at least 20% (absolute risk reduction of 5% or 5/1000 live births, from 25/1000 to 20/1000 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120009 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||FIRST BREATH: Neonatal Resuscitation in Developing Countries|
|Study Start Date :||March 2005|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
Experimental: NRP Training (Intervention)
Training in AAP neonatal resuscitation training program
|Procedure: Neonatal Resuscitation|
|Control||Procedure: Neonatal Resuscitation|
- Neonatal mortality [ Time Frame: 7 days ]
- Neonatal mortality due to perinatal asphyxia [ Time Frame: 7 days ]
- Hypoxic ischemic encephalopathy [ Time Frame: 7 days ]
- Need for advanced resuscitation [ Time Frame: 7 days ]
- Apgar score at 5 minutes [ Time Frame: 5 minutes ]
- Perinatal mortality at 7 days [ Time Frame: 7 days ]
- Stillbirth or neonatal mortality [ Time Frame: 7 days ]
- Stillbirth and/or neonatal mortality at 28 days [ Time Frame: 28 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00136708
|Buenos Aires, Argentina|
|Guatemala City, Guatemala|
|Bhubaneswar, Orissa, India|
|Principal Investigator:||Waldemar Carlo, MD||University of Alabama at Birmingham|