Clinical Trial: Global Network Implementation of Helping Babies Breathe (HBB)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Global Network for Women's and Children's Health Research Does Implementation of HELPING BABIES BREATHE (HBB) Save Lives?
Brief Summary: The primary purpose of this pre-post evaluation is to test the impact on perinatal mortality (fresh stillbirths or early neonatal deaths) among births > 1500g of training birth attendants at health facilities in the Helping Babies Breathe (HBB) and Essential Newborn Care (ENC) curricula. These facilities are located within clusters in the Global Network for Women's and Children's Health Research sites in Belgaum and Nagpur, India, and Eldoret, Kenya.
Detailed Summary:
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:
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Sponsor: NICHD Global Network for Women's and Children's Health
- Facility-based perinatal mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]The difference in the rate of facility-based perinatal mortality, among births ≥1500g pre versus post implementation of HBB/ENC training and equipment.
- Retention of resuscitation knowledge and skills [ Time Frame: Assessments completed at initial training and refresher training. ]The difference pre versus post intervention in mean scores on a multiple choice test of resuscitation knowledge, observed skills in bag and mask ventilation (BMV), and OSCE A and OSCE B scenarios.
- Number of neonatal resuscitations [ Time Frame: Resuscitation data collected at 6 weeks post-delivery. ]The difference in the number of neonatal resuscitations, among births ≥1500g with bag and mask in participating facilities pre versus post HBB/ENC training and equipment.
- Delivery room checklist score [ Time Frame: Observations conducted on a monthly basis. ]The difference in scores on delivery room checklist (in facilities with > 100 deliveries/year)
- Asphyxia related perinatal mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]The difference in the rate of asphyxia related perinatal mortality, among births ≥1500g pre versus post HBB/ENC training.
- Health seeking behavior [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
- Facility deliveries [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
- Very early newborn death (within 1 day of birth) [ Time Frame: Data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]The difference in very early newborn death (within 1 day of birth) pre versus post HBB/ENC training.
- In participating facilities, the facility-based perinatal mortality [ Time Frame: Study Duration ]The difference in the rate of facility-based perinatal mortality, among births >1500g pre versus post implementation of HBB/ENC training and equipment.
- In participating facilities, the impact on resuscitation [ Time Frame: Study Duration ]The difference in resuscitation knowledge and observed skills in bag and mask ventilation, among births >1500g pre versus post HBB/ENC training and equipment implementation
- In participating facilities, the number of neonatal resuscitations [ Time Frame: Study Duration ]The difference in the number of neonatal resuscitations, among births >1500g with bag and mask in participating facilities pre versus post HBB/ENC training and equipment.
- In participating facilities, the delivery room checklist [ Time Frame: Study Duration ]The difference in scores on delivery room checklist, among births >1500g pre versus post HBB/ENC training and equipment.
- Asphyxia related perinatal mortality [ Time Frame: Study Duration ]The difference in the rate of asphyxia related perinatal mortality, among births >1500g pre versus post HBB/ENC training.
- Health seeking behavior [ Time Frame: Study Duration ]The difference in the proportion of health seeking behavior pre versus post HBB/ENC training.
- Facility deliveries [ Time Frame: Study Duration ]The difference in the proportion of facility deliveries pre versus post HBB/ENC training.
Current Primary Outcome: Perinatal Mortality [ Time Frame: Perinatal mortality data collected at 6 weeks post-delivery. Comparison will include the pre-intervention period of 12 months and the post-intervention period of 12 months. ]
Original Primary Outcome: Perinatal Mortality [ Time Frame: Study Duration ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: NICHD Global Network for Women's and Children's Health
Dates:
Date Received: September 4, 2012
Date Started: September 2012
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015
