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First Breath: Neonatal Resuscitation in Developing Countries

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ClinicalTrials.gov Identifier: NCT00136708
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : July 31, 2014
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health

Tracking Information
First Submitted Date  ICMJE August 25, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date July 31, 2014
Study Start Date  ICMJE March 2005
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
Neonatal mortality [ Time Frame: 7 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
Neonatal mortality at 7 days
Change History Complete list of historical versions of study NCT00136708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2005)
  • Neonatal mortality due to perinatal asphyxia
  • Hypoxic ischemic encephalopathy
  • Need for advanced resuscitation
  • Apgar score at 5 minutes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Breath: Neonatal Resuscitation in Developing Countries
Official Title  ICMJE FIRST BREATH: Neonatal Resuscitation in Developing Countries
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 Program/Essential 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 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Asphyxia Neonatorum
Intervention  ICMJE Procedure: Neonatal Resuscitation
Study Arms  ICMJE
  • Experimental: NRP Training (Intervention)
    Training in AAP neonatal resuscitation training program
    Intervention: Procedure: Neonatal Resuscitation
  • Control
    Intervention: Procedure: Neonatal Resuscitation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 29, 2014)
120009
Original Enrollment  ICMJE
 (submitted: August 25, 2005)
16000
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Live births with a weight ≥ 1500 grams (community minimum)
  • Infants born in participating communities

Exclusion Criteria:

  • Stillbirths
  • Infants with suspected/confirmed lethal malformations (e.g. anencephaly, Trisomy 13 or 18, or cyanotic or left-sided congenital heart disease that will not be repaired)
  • Any infant who is transported/brought to the center after delivery
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Congo,   Guatemala,   India,   Pakistan,   Zambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136708
Other Study ID Numbers  ICMJE CP02 FIRST BREATH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NICHD Global Network for Women's and Children's Health
Study Sponsor  ICMJE NICHD Global Network for Women's and Children's Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
PRS Account NICHD Global Network for Women's and Children's Health
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP