Appendix 2: MANDATE Model Intervention Assumptions for Sub-Saharan Africa (SSA)/India

Appendix 2: MANDATE model intervention assumptions for sub-Saharan Africa (SSA)/India

Parameter type / Definition / Parameter / %
Home / %
Clinic / % Hospital / Description
Intrapartum event
Diagnosis / Recognition of need for resuscitation / Penetration / 75%/50% / 80% / 98% / WHO defines neonates in need of resuscitation: all babies who do not cry, do not breathe at all, or who are gasping 30 second after birth(WHO 1998). Based on this definition, MANDATE assumes nearly universal penetration of the ability to recognize failure to breathe in hospital settings, with a lower penetration in clinical and home settings due to a larger proportion of deliveries with no skilled birth attendant and/or limited access to stethoscopes by which to determine if a live birth or a stillbirth(Manasyan, Saleem et al. 2013). In India, 30-57% of mothers reported knowing neonatal danger signs indicative of the need for resuscitation (Unicef 2009).
Utilization / 75%/70% / 80% / 90% / MANDATE assumes high, but not universal, utilization the knowledge regarding need for resuscitation, with the highest levels of appropriate utilization in facility settings.
Efficacy (to diagnose) / 98% / 98% / 98% / The ILCOR statement on neonatal resuscitation states that the decision to resuscitate is based on a “compound assessment," including initial cry, breathing, tone, heart rate, maturity, and response to stimulation (Perlman, Wyllie et al. 2010). MANDATE model assumption: the simplified WHO definition of neonates in need of resuscitation (no cry, no breath, or gasping at 30 seconds after birth) (WHO 1998) would identify nearly all neonates needing resuscitation, compared to ILCOR algorithm as gold standard.
Treatment / Manual Stimulation / Penetration / 50% / 99% / 99% / Approximately half of deliveries are prepared for manual stimulation of the neonate in a home setting, as approximately half of women have a skilled birth attendant in the home (Unicef 2009). MANDATE assumes that penetration of manual stimulation is nearly universal in clinical/hospital settings.
Utilization / 75%/50% / 90%/50% / 95%/70% / SSA: In Tanzania and Ghana, studies examining delivery practices in home settings reported that 29-33% of mothers reported that the neonate was dried within 5 minutes(Hill, Tawiah-Agyeman et al. 2010; Penfold, Hill et al. 2010). In facilities, 42% reported that the neonate was dried within 5 minutes. High levels of manual stimulation (95%) are reported by TBAs(Garces, McClure et al. 2012), but there may be lower observed levels in some settings(National Coordinating Agency for Population and Development (NCAPD) [Kenya] 2011).
India: In a studies of home births in India and Sri Lanka, utilization rates range from 70% to80% (Gupta, Srivastava et al. 2010; Sartaj 2012; Upadhyay, Rai et al. 2012). High levels of manual stimulation (95% and higher) are reported within hospital settings(Senarath, Fernando et al. 2007). MANDATE assumes lower utilization rates in clinics than hospitals.
Efficacy (to reduce mortality) / 15% / 15% / 15% / A DELPHI panel estimated that immediate newborn assessment and stimulation would reduce birth asphyxia mortality by 10% (IQR: 5-15%; Range: 0-25%) (Lee, Cousens et al. 2011). Based on other estimates of stimulation on mild asphyxia in LIC settings (Bang, Bang et al. 2005; Wall, Lee et al. 2010)), MANDATE assumes 15% efficacy to prevent mortality.
Treatment / Resuscitation/Bag-Mask Ventilation / Penetration / 10%/5% / 80/50% / 99%/95% / MANDATE assumes negligible penetration of ventilation equipment in home settings.
SSA: Service Provision Assessment (SPA) surveys from 5 sub-Saharan African countries indicate bag-mask penetration of 40% in clinics (median: 36%; range: 29-72%) and >90% in hospitals (median: 92%; range: 70-95%) (National Bureau of Statistics (NBS) [Tanzania] 2007; Ministry of Health (MOH) [Uganda] and Macro International Inc 2008; National Institute of Statistics (NIS) [Rwanda] 2008; Ministry of Health and Social Services (MoHSS) [Namibia] and ICF Macro 2010; National Coordinating Agency for Population and Development (NCAPD) [Kenya] 2011). A more recent study of EmOC signal function availability, showed that of 218 BEmOC facilities, 50% had equipment needed to perform neonatal resuscitation (Spector, Reisman et al. 2013).
India: In South Asia, 80% and 100% availability of bag and mask ventilation is reported in health institutions (clinics) and hospitals, respectively (Nelson and Spector 2011; Ameh, Msuya et al. 2012).
Utilization / 20% / 50%/40% / 75%/60% / In home settings, 13-31% utilization is reported in settings with available bag/mask ventilation (Carlo, Goudar et al. 2010)
SSA: In LIC settings, 27% of deliveries occurred in facilities with staff trained in neonatal resuscitation (Lawn, Kinney et al. 2009). In a cross-sectional evaluation of 1,500 skilled birth attendants in five countries, 50% were competent to perform neonatal resuscitation with a bag and mask (Harvey, Blandón et al. 2007). MANDATE assumes higher levels of utilization in hospital vs clinic settings.
India: Surveys of Indian hospitals from the Global Network (2012 unpublished data) report utilization rates between 30-90%.
Efficacy (to reduce mortality) / 40% / 40% / 40% / In a meta-analysis of three studies (report here), training in neonatal resuscitation in facilities was associated with a 30% reduction in intrapartum-related mortality (RR =0.70; 95%CI: 0.59-0.84) (Lee, Cousens et al. 2011). The effect appears to be higher in higher mortality settings (approximately 50%) (Bang, Bang et al. 2005; O'Hare, Nakakeeto et al. 2006); however, evidence is limited.
Diagnosis / Home recognition of intrapartum-related injury / Penetration / 50% / n/a / n/a / Mothers in LIC settings recognize a sick newborn approximately one-quarter of the time (Kamath‐Rayne, MacGuire et al. 2011). MANDATE assumes that penetration and utilization are approximately equivalent in the absence of additional data.
Utilization / 50% / n/a / n/a / Mothers in LIC settings recognize a sick newborn approximately one-quarter of the time (Kamath‐Rayne, MacGuire et al. 2011). MANDATE assumes that penetration and utilization are approximately equivalent in the absence of additional data.
Efficacy (to diagnose) / 58% / 58% / 58% / All babies who require extensive resuscitation should have ongoing assessment for at least 12-24 hours after birth. Clinical algorithms for the identification of a sick neonate have a mean sensitivity of approximately 87% (Kamath‐Rayne, MacGuire et al. 2011). MANDATE assumes simplified danger signs would have a decreased efficacy for the identification of a sick neonate similar to community health worker sensitivity (approximately 58%) (Kamath‐Rayne, MacGuire et al. 2011)
Diagnosis / Clinical diagnosis of intrapartum-related injury / Penetration / n/a / 80% / 90% / MANDATE assumes high penetration of clinical diagnosis or intrapartum-related injury among skilled birth attendants who have the ability to identify neonates with respiratory, cardiac, or other instabilities.
Utilization / n/a / 50% / 75% / There are no data regarding the frequently of clinical diagnosis of intrapartum-related injury in clinical settings. MANDATE assumes that diagnosis is utilized in a timely and clinically appropriate manner in half of clinical cases and in 75% of hospital cases.
Efficacy / 87% / 87% / 87% / All babies who require extensive resuscitation should have ongoing assessment for at least 12-24 hours after birth. Clinical algorithms for the identification of a sick neonate have a mean sensitivity of approximately 87% (Kamath‐Rayne, MacGuire et al. 2011).
Treatment / Oxygen, Pulse Ox, Antibiotic / Penetration / 0% / 30%/15% / 80%/60% / No penetration/utilization of oxygen with supportive care in home settings.
SSA and India: Oxygen reported to be available in 70% of low income country health care facilities. Facilities (low and middle income countries included) with the fewest deliveries had oxygen availability of approximately 20%, while facilities with moderate and high volume of deliveries had availability of 70 and 90% availability(Spector, Reisman et al. 2013).
SSA: Global Network reports 15% of clinics and 60% of hospitals always have oxygen available.
India: Global Network reports 31% of clinics and 83% of hospitals always have oxygen available (Manasyan, Saleem et al. 2013).
Utilization / 0% / 50% / 75% / WHO reports that, when prescribed by doctors, 60% of children received it on hospital wards (World Health Organization 2003). MANDATE assumes lower levels of oxygen utilization in clinical settings and higher levels in hospital settings.
Efficacy (to reduce mortality) / 25% / 25% / 25% / In neonates needing additional respiratory support, oxygen is estimated to reduce neonatal mortality by 25%(Kamath, Macguire et al. 2011). Note: data regarding respiratory and supportive care are primarily derived from preterm populations with respiratory distress or apnea.
Treatment / CPAP / Penetration / 0% / 2% / 20% / No penetration/utilization of CPAP with supportive care in home settings.
In the absence of data regarding the availability of CPAP in facilities, MANDATE assumes negligible penetration of CPAP in clinics andthat level 2 and 3 hospitals will have some penetration of CPAP in low and middle income countries(Ralston, Day et al. 2013).
Utilization / 0% / 50% / 75% / No penetration/utilization of CPAP with supportive care in home settings. There are no data regarding the utilization of CPAP in clinical settings. MANDATE assumes that CPAP is utilized in a timely and clinically appropriate manner in half of clinical cases and in 75% of hospital cases.
Efficacy (to reduce BAI mortality) / 50% / 50% / 50% / From a Cochrane review, CPAP was associated with a lower rate of failed treatment (death or use of assisted ventilation) (RR 0.70: 95%CI: 0.55, 0.88), and mortality (RR 0.52: 95%CI: 0.32, 0.87) (Ho et al 2002). CPAP has been estimated to reduce mortality in infants needing respiratory support by approximately 50%(Kamath, Macguire et al. 2011) Note: data regarding respiratory and supportive care are primarily derived from preterm populations with respiratory distress or apnea.
Treatment: / NICU/Ventilation / Penetration / 0% / 0% / 15%/10% / NICU/Ventilation not available in home or clinic settings. MANDATE assumes that level 3 hospitals will have some penetration of NICU/mechanical ventilation in low and middle income countries (Ralston, Day et al. 2013).
Utilization / 0% / 0% / 90% / NICU/Ventilation not utilized in home or clinic settings. There are no data regarding the utilization of mechanical ventilation in clinical settings. MANDATE assumes that mechanical ventilation is utilized in a timely and clinically appropriate manner in 90% of level 3 hospitals.
Efficacy to reduce BAI mortality / 25% / 25% / 25% / Trials from the 1960s demonstrated an overall reduction in mortality among neonates with severe respiratory failure of 14% (RR 0.86; 95%CI: 0.74, 1.00). Among neonates weighing >2 kg, the reduction in mortality was 33% (RR 0.67; 95%CI: 0.52, 0.87)(Henderson-Smart, Wilkinson et al. 2002). Ventilation from the 1960s cannot be compared to modern methods of ventilation. And, no modern trials have been conducted for mechanical ventilation for ethical reasons. MANDATE assumes that NICU/ventilation is a second-line treatment that is estimated to reduce mortality over and above oxygen/CPAP support by approximately 25% (Kamath, Macguire et al. 2011). Note: data regarding respiratory and supportive care are primarily derived from preterm populations with respiratory distress or apnea.
Transfer / Transfer after recognition/diagnosis of need for post-resuscitaton care / Home to clinic / 20% / Among neonates with illness/suspected illness, 24-50% sought care from an institution (Ahmed, Sobhan et al. 2001; Dongre, Deshmukh et al. 2009; Owais, Sultana et al. 2011) (Dongre et al, 2009; Ahmed et al, 2001; Owais et al, 2001). Care is more likely to be sought at a hospital than clinic (Dongre, Deshmukh et al. 2009)
Home to hospital / 30%
Clinic to hospital / 50% / MANDATE assumes higher transfer from clinic to hospital due neonatal illness (Unicef 2009).

*where two estimates are provided, the first is India and the second is sub-Saharan Africa

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