Clinical trial NCT00136708: First Breath: Neonatal Resuscitation in Developing Countries
Official title: FIRST BREATH: Neonatal Resuscitation in Developing Countries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
First posted: 2005-08-29
Enrollment: 120009
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Neonatal mortality
timeFrame: 7 days
Secondary outcomes:
measure: Neonatal mortality due to perinatal asphyxia
timeFrame: 7 days
measure: Hypoxic ischemic encephalopathy
timeFrame: 7 days
measure: Need for advanced resuscitation
timeFrame: 7 days
measure: Apgar score at 5 minutes
timeFrame: 5 minutes
measure: Perinatal mortality at 7 days
timeFrame: 7 days
measure: Stillbirth or neonatal mortality
timeFrame: 7 days
measure: Stillbirth and/or neonatal mortality at 28 days
timeFrame: 28 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Kinshasa
country: Congo
city: Guatemala City
country: Guatemala
city: Bhubaneswar
country: India
state: Orissa
city: Belgaum
country: India
city: Karachi
country: Pakistan
city: Lusaka
country: Zambia
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.