Table 1 Characteristics of included studies

Bang 1999 [38]

Cluster RCT

Gadchiroli district of India which is about 1000 km from the state capital, Mumbai. It is underdeveloped district, with poor infrastructure (poor roads, communications, education, and health services)

Newborns in 39 intervention and 47 control villages (2869 and 3122 newborns, respectively)

1209/1315

Neonatal mortality, stillbirth, perinatal mortality, and cause of neonatal death

Baqui 2016 [39]

Cluster RCT

Beanibazar, Zakiganj and Kanaighat subdistricts of Sylhet division of Bangladesh

Newborns within the general community of the Sylhet district in rural northeast Bangladesh (9630 and 9852 newborns in the intervention and control groups, respectively)

380/389

Neonatal mortality and cause-specific neonatal mortality

Bashour 2008 [33]

RCT

A maternity teaching hospital in Damascus, Syria

A total of 876 women were followed up in the three study groups: group A (285 women) 4 PNC visit; group B (294 women) 1 PNC visit; and group C (297 women) no visit (control)

577/296 for NMR and 498/258 for EBF outcome

Maternal postpartum morbidities; postnatal care uptake; contraceptive uptake and type; infant morbidities; infant immunization at three months; and exclusive breastfeeding during the first four months of life.

Bhandari 2012 [44]

Cluster RCT

The trial was conducted in communities with a population of 1.1 million served by 18 primary health centers in the district of Faridabad, Haryana, India

29,667 and 30,813 newborns in intervention and control clusters, respectively

29,667/30,813 for NMR and 6204/6163 for EBF outcome

Neonatal and infant mortality; newborn care practices, exclusive breastfeeding at 4 weeks

Coutinho 2005 [37]

RCT

Urban areas of Palmares and three neighboring small towns (Catende, Água Preta, and Joaquim Nabuco) in the interior of the State of Pernambuco, northeastern Brazil). The area is hilly and lies 130 km southwest of Recife, the State capital.

175 control and 175 intervention mother and their newborn/infants

175/175

Rates of exclusive breastfeeding at 12 weeks of age over 24 h recall and breastfeeding practices

Compared the hospital-based intervention with a combined hospital-based and community-based

Darmstadt 2010 [45]

Cluster RCT

The trial was implemented in Mirzapur, a sub-district of Tangail district, Dhaka Division, Bangladesh, located 2 h by car from the capital city of Dhaka

4616 and 5241 live births were recorded from 9987 and 11,153 participants in the comparison and intervention arm

301/265

Antenatal and immediate newborn care behaviors, knowledge of danger signs, care-seeking for neonatal complications, and neonatal mortality.

Kirkwood 2013 [29]

Cluster RCT

Undertaken in seven predominantly rural districts in the Brong Ahafo Region, Ghana: Kintampo North, Kintampo South, Nkoranza North, Nkoranza South, Tain, Techiman, and Wench

11,419 and 11,144 newborn and mothers in intervention and control groups, respectively

11,419/11,144 for NMR and 1414/1371 for EBF outcome

Neonatal mortality rate and coverage of key essential newborn-care practices; exclusive breastfeeding in the previous 24 h between days 26 to 32 after birth

Same study area with “Pitt 2016”

Kumar 2008 [27]

Cluster RCT

Shivgarh, a rural block in Uttar Pradesh, with a population of 104,123. Socioeconomic indicators are among the lowest in the state.

1522 intervention and 1079 control groups of mothers and newborn in Shivgarh

1522/1079

Changes in newborn care practices and neonatal mortality rate compared with the control group

LeFevre 2013 [40]

Cluster RCT

Beanibazar, Zakiganj and Kanaighat subdistricts of Sylhet division; a division which has a higher level of neonatal mortality and a higher fertility rate than any of the other five of Bangladesh’s divisions

364 and 750 mothers and newborns in intervention and control groups, respectively

364/750

Cost-effectiveness of two strategies (home and community care) for neonatal and maternal care

Neonatal mortality is reported in “Baqui 2016”.

Memon 2015 [41]

quasi-experimental

Gilgit district which is situated about 600 km away from Islamabad, the capital of Pakistan. The population of district Gilgit is around 283,324, the majority of which are subsistence farmers. The health infrastructure comprised of three Basic Health Units, one Rural Health Centre, five Civil Hospitals and one District Head Quarter Hospital.

833 and 842 mothers and newborns in the intervention and control groups, respectively, in a remote mountainous district in Northern Pakistan

458/463

Changes in maternal and newborn care practices and perinatal and neonatal mortality rates

Pitt 2016 [43]

Cluster RCT

Undertaken in seven predominantly rural districts in the Brong Ahafo Region, Ghana: Kintampo North, Kintampo South, Nkoranza North, Nkoranza South, Tain, Techiman, and Wench

11,419 mothers and their newborns in intervention and 11,144 Mothers and their newborns in control groups in seven districts of rural Ghana

11,419/11,144

Cost-effectiveness of home visits to women and their newborns for interventions and cost per newborn saved life.

Neonatal mortality is reported in “Kirkwood 2013”

Soofi 2017 [42]

Cluster RCT

Naushahro Feroze district of rural Sindh. The district is located 450 km north of Karachi with a population of around 1·3 million

736 mothers and newborns in intervention and 1050 mothers and newborns in control groups

736/1050

All-cause neonatal mortality

Tyllerskr 2011 [36]

Cluster RCT

The study was undertaken in rural Banfora, southwest Burkina Faso, Mbale District, eastern Uganda, and Paarl (a periurban site close to Cape Town), Umlazi (periurban site near Durban), and Rietvlei (rural Kwa Zulu Natal), South Africa.

2579 mother-infant pairs to the intervention or control clusters

1323/1256

Prevalence of exclusive breastfeeding and diarrhea reported by mothers regarding infants aged 24 weeks over 24 h recall

Waiswa 2015 [47]

Cluster RCT

Iganga and Mayuge districts in eastern Uganda, within the Iganga-Mayuge Health and Demographic Surveillance Site (HDSS). The HDSS is predominately rural, comprising 65 villages and a total population of approximately 70,000.

894 and 893 mothers and newborns in the intervention and control groups, respectively

894/893

Coverage of key essential newborn care behaviors (breastfeeding, thermal care, and cord care); exclusive breastfeeding over neonatal period

Health facility strengthening was done to improve the quality of care in all intervention and control sites