Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
HBB/ENC supplies
+ HBB/ENC Training and Equipment
+ HBB/ENC Training and Equipment
Enfermedades Urogenitales+6
+ Muerte
+ Enfermedades Urogenitales Femeninas y Complicaciones del Embarazo
Estudio de Investigación en servicios de salud
Resumen
Fecha de inicio: 1 de septiembre de 2012
Fecha en la que se inscribió al primer participante.Helping Babies Breathe (HBB) is a training program designed to resuscitate neonates regardless of where they were born. HBB was developed by the American Academy of Pediatrics (AAP), the NICHD's Global Network for Women's and Children's Health (GN), the Laerdal Foundation and their global partners. The HBB program was developed based upon the experience and results of an earlier Neonatal Resuscitation Program and the GN's FIRST BREATH randomized control trial. The goal of the study is to test the impact of training birth attendants at selected health facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula upon perinatal mortality (fresh stillbirths and early neonatal deaths), among births of ≥1500g. The training will take place in three GN sites, Kenya, and Nagpur and Belgaum, India. The study facilities serve the population in identified study clusters, defined geographic areas which participate in the GN's Maternal Newborn Health (MNH) Registry. In addition to measuring perinatal mortality rate pre and post training, the study will also assess resuscitation skills among the birth attendants as a result of the training. Quality Improvement activities are planned to ensure the integrity of the training, maintenance and availability of resuscitation equipment and skills maintenance. The GN MNH Registry (NCT 01073475) was established in 2008 and includes all pregnancies and neonatal outcomes in defined geographic clusters. The primary outcome for the pre-post HBB evaluation study will be calculated using all delivery data from the GN MNH Registry for participating clusters during the defined study period. The pre-post HBB evaluation will include the following key activities: Selection of Master Trainers, Facilitators, and Learners Country-level training of Master Trainers in the HBB and ENC curricula Facility-level training of birth attendants in the HBB and ENC curricula Periodic re-training of birth attendants in the HBB and ENC curricula Quality improvement activities: Regular observation of deliveries in participating study health facilities Unannounced observation of deliveries (or HBB skills using a neonatal simulator if no deliveries are available) Resuscitation debriefings Perinatal Death audits Daily bag and mask ventilation practice Drills to practice emergency drills Daily check of cleanliness and availability of resuscitation equipment. The HBB Master Trainers (MT), Facilitators, and Learners will be evaluated at several points during the implementation of the training program and quality improvement activities.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 70.704 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Investigación en Servicios de Salud
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 16 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Facilities: at least 60 deliveries per year; ability to provide 24-hour coverage, 7 days per week in the delivery ward; and minimum perinatal mortality rate of 30 per 1000 deliveries in the reference period. Master Trainers (MT) Experienced teachers and content experts in neonatal resuscitation Trained and/or experienced in education Dedication to learner-focused education Able to give informed consent Facilitators Experienced in teaching Learners in small groups Experienced in care of newborns Demonstrated understanding of course content Aptitude for teaching Able to give informed consent Learners Skilled birth attendants with clearly defined responsibilities for attending deliveries at participating facilities Able to give informed consent Exclusion Criteria: If a facility, master trainer, facilitator, or learner does not meet the above inclusion criteria they are excluded from the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.4 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
Grupo II
Grupo III
Grupo IV
Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 3 ubicaciones
Jawaharlal Nehru Medical College
Belagavi, IndiaAbrir Jawaharlal Nehru Medical College en Google MapsLata Medical Research Foundation
Nagpur, IndiaMoi University School of Medicine
Eldoret, Kenya