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


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

* 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).

Imdad et al. BMC Public Health 2013 13(Suppl 3):S15   doi:10.1186/1471-2458-13-S3-S15

Open Data