Clinical Trial: First Breath: Neonatal Resuscitation in Developing Countries

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Summary:

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
Sponsor: NICHD Global Network for Women's and Children's Health

Current Primary Outcome: Neonatal mortality [ Time Frame: 7 days ]

Original Primary Outcome: Neonatal mortality at 7 days

Current Secondary Outcome:

  • 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:

  • Neonatal mortality due to perinatal asphyxia
  • Hypoxic ischemic encephalopathy
  • Need for advanced resuscitation
  • Apgar score at 5 minutes


Information By: NICHD Global Network for Women's and Children's Health

Dates:
Date Received: August 25, 2005
Date Started: March 2005
Date Completion:
Last Updated: July 29, 2014
Last Verified: July 2014