Table 2 Characteristics of included studies
Study characteristics | Nepal trial* | Bangladesh trial | Pakistan trial |
|---|---|---|---|
Type of study | Cluster RCT | Cluster RCT | 2 × 2 factorial design cluster RCT |
No. clusters (average size) | 413 (700) | 133 (4100) | 187 (1000) |
Sample size total | 15,123 | 29,760 | 9,741 |
Average sample size per group | ~ 5,050 | ~ 9,900 | ~ 4,850 |
Duration of trial | Nov 2002 to Mar 2005 | Jun 2007 to Sep 2009 | Jan 2008 to Jun 2009 |
Overall NMR | 32/1000 | 36/1000 | 30/1000 |
% of home births | 92 % | 93 % | 80 % |
Inclusion criteria | All live births in the study area | All live births in the study area | All live births in the study area were included except those who were born in hospitals. |
Exclusion criteria | Not met within 10 days after birth | Didn’t receive intervention within 7 days after birth | Not met within 3 days after birth. Babies with congenital anomalies |
Comparison group | Dry cord care | Dry cord care | Dry cord care |
Intervention groups | 1.Multiple CHX 2.Soap/H2O | 1.Multiple CHX 2.Single CHX | 1.Multiple CHX 2.Handwashing (HW) 3.CHX + HW |
CHX concentration | 4.0 % | 4.0 % | 4.0 % |
Participants recruiters | Local female worker | CHWs | CHWs |
Intervention providers | Local project staff | Village health worker | TBA to caretaker |
Outcome assessors | (Nonmedical) field workers | CHWs | CHWs |
Basic interventions to all babies/mothers | CDK, FE/FA, TT, promotion of ANC/ENC | CDK. FE/FA, promotion of TT, ANC, birth preparedness, ENC | Basic component of ENC as promoted by Ministry of Health |
Primary outcomes | Omphalitis, neonatal mortality | Omphalitis, neonatal mortality | Omphalitis, neonatal mortality |
Follow up days | 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28 | 1,3,6,9,15,28 | 1,3,5,7,14,28 |