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Table 2 Characteristics of included studies

From: The effect of umbilical cord cleansing with chlorhexidine on omphalitis and neonatal mortality in community settings in developing countries: a meta-analysis

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
  1. RCT: Randomized Controlled trial, CHX: chlorhexidine, CDK: clean delivery kit, Fe/FA: Iron/Folic acid, TT, Tetanus oxide, ANC: Antenatal care, ENC: essential newborn care, CHW: Community Health Workers, TBA: Traditional Birth Attendant
  2. * Nepal trial was nested within a study of the effect of full-body skin cleansing with antiseptic on neonatal mortality. In that trial, newborns were given a single fullbody wipe with either 0·25% chlorhexidine or placebo solution immediately after birth. In each skin cleansing group (0·25% chlorhexidine or placebo) in the main trial, sectors were randomized to one of three cord-care regimens (Which makes total of 6 study groups).