LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

DR K. Kawaza University of Malawi College of Medicine

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

What is CPAP Why CPAP not widely available Work in Malawi on low cost bubble CPAP Pumani CPAP device + technical evaluation Clinical trial for efficacy Bubble CPAP roll out

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Background: 15 million babies born, 10% premature 1.1 million preterm babies die every year More than 1 million premature babies die shortly after birth, majority due to RDS or respiratory distress of other aetiology With inexpensive treatment 75 percent could survive
Born Too Soon: The Global Action Report on Preterm Birth

Background Malawi
Population: 15.3 million* Districts :28* MMR: 675/100,000* NMR: 31/1,000* IMR: 58/1,000** Preterm Birth rate: 18%* Oxygen from concentrators No neo ventilators, no CPAP No walled oxygen
Source: *DHS 2010; ** (2010 stat, WHS 2012)

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

CPAP:
CPAP well know effective therapy for respiratory distress Seen as intermediate option between simple O2 Rx and mechanical ventilation Improves oxygenation, reduces work of breathing, reduces need for ventilation Globally increasing trend in CPAP use

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL

RESPIRATORY DISTRESS IN MALAWI
Trend in ventilation and CPAP rates among neonates, NSW (New South Wales) 2001-2008

Roberts et al. BMC Pediatrics 2011, 11:89

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI
CPAP initiation for neonates > 32 weeks by type of hospital.

Roberts et al. BMC Pediatrics 2011, 11:89

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI
Potential for Low Cost bCPAP to improve mortality

Adapted from: Kamath, B.D., et al., Neonatal Mortality From Respiratory Distress Syndrome: Lessons for Low-Resource Countries. Pediatrics, 2011. 127(6): p. 1139-1146.

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

COST has been the major barrier..

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

CPAP
Flow generator Pressure regulator Oxygen input Patient interface

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Previous attempts at bCPAP in Malawi

*Air compressor (WhispairH CMC 90/10, Contimeta, Utrecht, the Netherlands; 700)

Van Den Heuvel et al, Annals of Tropical Paediatrics 2011.

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Low Cost Bubble CPAP For Reducing Mortality due to Neonatal Respiratory Distress
Background

Work in Malawi on low cost bubble CPAP

Since 2007; Collaboration COM, RICE University, BCM. Aim to come up with an effective but low cost, easy to use bCPAP. RICE provided technical expertise in design Malawi provided input for the design to adapt to local needs

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI
> By 2011, a prototype developed and tested against standard systems used at TCH in US

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI
TCH CPAP
16 14 12 10 8 6 4 2 0 0 1 2 3 4 5 6 7 8 9 10 Run Number 20 18 16 14 12 10 8 6 4 2 0 0 1 2 3 4 5 6 7 8 9 10 Run Number 16 14 12 10 8 6 4 2 0 0 1 2 3 4 5 6 7 8 9 10 Run Number 16 14 12 10 8 6 4 2 0 0 1 2 3 4 5 6 7 8 9 10 Run Number

Rice CPAP

Pressure (cm H2O)

4 cm H2O

Pressure (cm H2O)

8 cm H2O

Brown et al, 2013

Pressure (cm H2O)

Pressure (cm H2O)

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Brown et al, 2013

Evaluation of bCPAP use in Neonatal Respiratory Distress at QECH

Prospective, non-randomized convenience sample study.
Objectives of the study
To validate the therapeutic performance of the Rice bCPAP system for the Rx of respiratory distress, comparing it to the standard of care. Primary outcome: Mortality rate. Secondary outcomes: weight gain, length of time on resp support, and length of stay in the hospital.

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Study Inclusion Criteria

Diagnosed with respiratory distress, Breathing spontaneously, Weight a minimum of 1000 g bCPAP treatment is deemed appropriate

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Study Exclusion Criteria

Weight <1000 g Cleft palate, tracheo-esophageal fistula, diaphragmatic hernia, severe cardiac instability, severe birth asphyxia Not breathing spontaneously Not considered neurologically viable Treating clinician does not deem bubble CPAP to be the appropriate treatment.

Flow chart summarizing study procedure and outcome groups.

Identify neonates with severe respiratory distress who might benefit from CPAP; Treat with nasal oxygen and evaluate whether subject meets eligibility criteria
Eligible? Consent granted?

No Treat per standard of care

Yes No Monitor clinical progress on nasal oxygen No

CPAP still needed? Is CPAP available?

Yes

Yes

Is CPAP available?

Initiate treatment with CPAP

No

Yes

Follow outcomes as nasal oxygen group

Transition to CPAP

Follow outcomes as CPAP group

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

How far have we gone..?

Preliminary analysis suggests significant improvement in survival Prelim results shared with Government and Donors Final results to be published soon Funding already provided through USAID SLAB grant to roll out to secondary and tertiary hospitals

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Trial at QECH: Ensure equipment is robust & effective

Low Cost Bubble CPAP For Reducing Mortality due to Neonatal Respiratory Distress

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

bCPAP package

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Each central hospital rolls out to a district hospital

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

LOW COST BUBBLE CPAP FOR MANAGING NEONATAL RESPIRATORY DISTRESS IN MALAWI

Acknowledgements
Prof E. Molyneux Profs R. Kortum and M. Oden Unicef Malawi delegation Organizers and sponsors of the conference

THANK YOU