Appendix 2: MANDATE model intervention assumptions for sub-Saharan Africa (SSA)/India
Parameter
type
Intrapartum
event
Diagnosis
Treatment
Definition
Parameter
%
Home
%
Clinic
%
Hospital
Description
Recognition of need for
resuscitation
Penetration
75%/50%
80%
98%
Utilization
75%/70%
80%
90%
Efficacy (to
diagnose)
98%
98%
98%
Penetration
50%
99%
99%
Utilization
75%/50%
90%/50%
95%/70%
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).
MANDATE assumes high, but not universal, utilization the
knowledge regarding need for resuscitation, with the highest
levels of appropriate utilization in facility settings.
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.
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.
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
Manual Stimulation
Treatment
Resuscitation/Bag-Mask
Ventilation
Efficacy (to
reduce
mortality)
15%
15%
15%
Penetration
10%/5%
80/50%
99%/95%
Utilization
20%
50%/40%
75%/60%
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% to 80% (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.
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.
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).
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
Diagnosis
Diagnosis
Home recognition of
intrapartum-related injury
Clinical diagnosis of
intrapartum-related injury
Efficacy (to
reduce
mortality)
40%
40%
40%
Penetration
50%
n/a
n/a
Utilization
50%
n/a
n/a
Efficacy (to
diagnose)
58%
58%
58%
Penetration
n/a
80%
90%
Utilization
n/a
50%
75%
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 3090%.
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.
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.
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.
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)
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.
There are no data regarding the frequently of clinical
Treatment
Treatment
Oxygen, Pulse Ox,
Antibiotic
CPAP
Efficacy
87%
87%
87%
Penetration
0%
30%/15%
80%/60%
Utilization
0%
50%
75%
Efficacy (to
reduce
mortality)
25%
25%
25%
Penetration
0%
2%
20%
Utilization
0%
50%
75%
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.
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).
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).
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.
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.
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 and that level 2 and 3 hospitals will have
some penetration of CPAP in low and middle income
countries (Ralston, Day et al. 2013).
No penetration/utilization of CPAP with supportive care in
Treatment:
Transfer
NICU/Ventilation
Transfer after
recognition/diagnosis of
need for post-resuscitaton
care
Efficacy (to
reduce BAI
mortality)
50%
50%
50%
Penetration
0%
0%
15%/10%
Utilization
0%
0%
90%
Efficacy to
reduce BAI
mortality
25%
25%
25%
Home to
clinic
20%
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.
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.
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).
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.
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.
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
30%
hospital
Clinic to
50%
hospital
*where two estimates are provided, the first is India and the second is sub-Saharan Africa
MANDATE assumes higher transfer from clinic to hospital
due neonatal illness (Unicef 2009).
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