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First Breath: Neonatal Resuscitation in Developing Countries

Primary Purpose

Asphyxia Neonatorum

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Neonatal Resuscitation
Sponsored by
NICHD Global Network for Women's and Children's Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asphyxia Neonatorum focused on measuring Global Network, Neonatal mortality, Asphyxia, Maternal and child health, International, Zambia, Pakistan, India, Democratic Republic of Congo, Uruguay, Guatemala, Argentina, Neonatal resuscitation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

NRP Training (Intervention)

Control

Arm Description

Training in AAP neonatal resuscitation training program

Outcomes

Primary Outcome Measures

Neonatal mortality

Secondary Outcome Measures

Neonatal mortality due to perinatal asphyxia
Hypoxic ischemic encephalopathy
Need for advanced resuscitation
Apgar score at 5 minutes
Perinatal mortality at 7 days
Stillbirth or neonatal mortality
Stillbirth and/or neonatal mortality at 28 days

Full Information

First Posted
August 25, 2005
Last Updated
July 29, 2014
Sponsor
NICHD Global Network for Women's and Children's Health
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1. Study Identification

Unique Protocol Identification Number
NCT00136708
Brief Title
First Breath: Neonatal Resuscitation in Developing Countries
Official Title
FIRST BREATH: Neonatal Resuscitation in Developing Countries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NICHD Global Network for Women's and Children's Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum
Keywords
Global Network, Neonatal mortality, Asphyxia, Maternal and child health, International, Zambia, Pakistan, India, Democratic Republic of Congo, Uruguay, Guatemala, Argentina, Neonatal resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120009 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NRP Training (Intervention)
Arm Type
Experimental
Arm Description
Training in AAP neonatal resuscitation training program
Arm Title
Control
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Neonatal Resuscitation
Primary Outcome Measure Information:
Title
Neonatal mortality
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Neonatal mortality due to perinatal asphyxia
Time Frame
7 days
Title
Hypoxic ischemic encephalopathy
Time Frame
7 days
Title
Need for advanced resuscitation
Time Frame
7 days
Title
Apgar score at 5 minutes
Time Frame
5 minutes
Title
Perinatal mortality at 7 days
Time Frame
7 days
Title
Stillbirth or neonatal mortality
Time Frame
7 days
Title
Stillbirth and/or neonatal mortality at 28 days
Time Frame
28 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waldemar Carlo, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
City
Buenos Aires
Country
Argentina
City
Kinshasa
Country
Congo
City
Guatemala City
Country
Guatemala
City
Bhubaneswar
State/Province
Orissa
Country
India
City
Belgaum
Country
India
City
Karachi
Country
Pakistan
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
21816050
Citation
Matendo R, Engmann C, Ditekemena J, Gado J, Tshefu A, Kinoshita R, McClure EM, Moore J, Wallace D, Carlo WA, Wright LL, Bose C. Reduced perinatal mortality following enhanced training of birth attendants in the Democratic Republic of Congo: a time-dependent effect. BMC Med. 2011 Aug 4;9:93. doi: 10.1186/1741-7015-9-93.
Results Reference
derived
PubMed Identifier
20937655
Citation
Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Hambidge M, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Moore J, Wright LL; First Breath Study Group. High mortality rates for very low birth weight infants in developing countries despite training. Pediatrics. 2010 Nov;126(5):e1072-80. doi: 10.1542/peds.2010-1183. Epub 2010 Oct 11.
Results Reference
derived
PubMed Identifier
20164485
Citation
Carlo WA, Goudar SS, Jehan I, Chomba E, Tshefu A, Garces A, Parida S, Althabe F, McClure EM, Derman RJ, Goldenberg RL, Bose C, Krebs NF, Panigrahi P, Buekens P, Chakraborty H, Hartwell TD, Wright LL; First Breath Study Group. Newborn-care training and perinatal mortality in developing countries. N Engl J Med. 2010 Feb 18;362(7):614-23. doi: 10.1056/NEJMsa0806033.
Results Reference
derived
Links:
URL
http://gn.rti.org
Description
Global Network for Women's and Children's Health Research
URL
http://www.rti.org
Description
Research Triangle Institute International

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First Breath: Neonatal Resuscitation in Developing Countries

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