First Breath: Neonatal Resuscitation in Developing Countries

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier:
NCT00136708
First received: August 25, 2005
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Asphyxia Neonatorum
Procedure: Neonatal Resuscitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FIRST BREATH: Neonatal Resuscitation in Developing Countries

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

Primary Outcome Measures:
  • Neonatal mortality [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neonatal mortality due to perinatal asphyxia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Hypoxic ischemic encephalopathy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Need for advanced resuscitation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Apgar score at 5 minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Perinatal mortality at 7 days [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Stillbirth or neonatal mortality [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Stillbirth and/or neonatal mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 120009
Study Start Date: March 2005
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NRP Training (Intervention)
Training in AAP neonatal resuscitation training program
Procedure: Neonatal Resuscitation
Control Procedure: Neonatal Resuscitation

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00136708

Locations
Argentina
Buenos Aires, Argentina
Congo
Kinshasa, Congo
Guatemala
Guatemala City, Guatemala
India
Bhubaneswar, Orissa, India
Belgaum, India
Pakistan
Karachi, Pakistan
Zambia
Lusaka, Zambia
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
Investigators
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided by NICHD Global Network for Women's and Children's Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00136708     History of Changes
Other Study ID Numbers: CP02 FIRST BREATH
Study First Received: August 25, 2005
Last Updated: July 29, 2014
Health Authority: United States: Federal Government

Keywords provided by NICHD Global Network for Women's and Children's Health:
Global Network
Neonatal mortality
Asphyxia
Maternal and child health
International
Zambia
Pakistan
India
Democratic Republic of Congo
Uruguay
Guatemala
Argentina
Neonatal resuscitation

Additional relevant MeSH terms:
Asphyxia
Asphyxia Neonatorum
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 16, 2014