IFGH 2012: In Gestation: A Proposal to Implement a Cluster Randomized Control Trial (ICRCT) of the Helping Baby Breath (HBB) Program to Village Midwives (VMs) in Sudan

January 27, 2012

Authors:Ibriham S.1, Ahmed S2, Hamid A3, Saeed E4, Clark L5, Denk R6, Dempsey G2, Ryan CA2

Author Affiliations: 1Department of Paediatrics, University of Khartoum, Sudan, 2University College Cork, Ireland, 3Alneelain University, Sudan, 4Faculty of Nursing Science, University of Khartoum, Sudan. 5Sunnybrook Hospital, New York, 6Darfur, Sudan, 7University of Alabama at Birmingham, US

Option 1– Scientific / Empirical Research Findings

Presented as – Poster

Background:

Every year an estimated four million newborns die during their first month of life, 50% dying during delivery and the first 24 hours of life. HBB is a low-cost, neonatal resuscitation curriculum developed for resource-limited circumstances. HBB emphasizes skilled attendance at birth, assessment of every baby, temperature support, stimulation to breathe, and assisted ventilation if necessary, within “The First Golden Minute” after birth.

Aims:

The aim of this paper is to propose an ICRCT of HBB into rural Sudan, focusing on training 14,000 VMs, distributed over 18 Regions/provinces and covering a rural population of 25 million.

Methodology:

An ICRCT is a trial in which groups of subjects (in this case, villages) are randomized. Advantages of ICRCT over individually RCT include the ability to study interventions while preventing “contamination” across individuals. Approximately 200 Clusters with 200-300 annual deliveries per cluster will be sufficient to obtain statistical power.

Implementation:

Following cluster randomization, Regional Instructors (RIs) will be trained by HBB Master Trainers. RIs will then train HBB to the VMs in the villages randomized to the intervention group. Accurate outcome data collection will be essential to the project. Thus, VMs in both the control and treatment groups will be trained on how to accurately collect perinatal outcome data. The control villages would be “controls in waiting” in that they would receive HBB training once the outcome of the trial was confirmed as positive.

The Outcomes:

Stillbirth rates and neonatal death in the first 7 days will be the primary outcomes. Many babies currently classified as stillborn in national statistics, will often survive with effective resuscitation. In situations where neonatal follow up is questionable, neonatal mortality within 24 hours of birth will be analyzed.

Conclusion:

ICRCTs are a powerful and feasible way to address important educational initiatives in resource poor countries.

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