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Table 1 Summary table of trials

From: RETRACTED ARTICLE: Application of 4% chlorhexidine to the umbilical cord stump of newborn infants in lower income countries: a systematic review and meta-analysis

Study

Design and Sample size

Interventions

Comparator

Primary outcome/Other outcomes

Jamil,2018/Pakistan [20], Trial registration: Not found

Hospital-based RCT.

I = 50

C = 50

T = 100

Chlorhexidine (liquid or gel form) were applied once daily for 7 days or till umbilical cord falls off.

Dry cord care

Presence of omphalitis was recorded as 38% in Dry care and 10% in the chlorhexidine group (p = 0.001)

Lyngdoh, D [18], 2018/ India, Trial registration: CTRI/2017/07/009146.

Hospital-based trial

I = 35 (Chlorhexidine)

C = 35 (Dry cord care)

T = 105

He used chlorhexidine 4% as well as human breast milk in intervention arm

Dry cord care

4% chlorhexidine is very effective in reducing pathogenic bacteria colonization of the cord

Semrau, 2016/Zambia [13], Trial registration: NCT01241318

Cluster RCT.

Ia=18,450

Cb=19,308

Tc=37,758

Topical application of 4% chlorhexidine once per day until 3 days after cord drop.

Clean dry cord care

NMRd: 15·2/1000 live birth in IGe

NMR: 13·6/1000 live births CGf

Sazawal, 2016/Tanzania [14], Trial registration: NCT01528852

Community-based RCT.

I = 18,015

C = 18,896

T = 36,911

4% chlorhexidine solution to the cord every day until 3 days after the cord had dropped off.

Dry cord care

NMR: 10.5/1000 live birth in IG

NMR: 11.7/1000 live births CG

Khairuzzaman, 2015/ Bangladesh [21], Trial registration: Not found

Hospital-based RCT. I = 170

C = 170

T = 340

4% chlorhexidine solution

Dry cord care

The mean cord separation time in newborns of IG was significantly longer than CG (7.44 ± 3.75 Vs 4.83 ± 2.05 p < 0.001).

Mullany, 2013/Bangladesh [19], Trial registration: NCT00434408

Cluster-RCT

I = 17,757

C = 9624

T = 27,381

Three arms IG:

1)4% chlorhexidine,

2) cleansing with soap and water

Dry cord care.

Cord separation time

1) Single group: 6.9 ± 2.87 days,

2) Multiple groups: 7.49 ± 3.08 days

3) Dry care: 4.78 ± 1.82 days

Sofi S, 2012/Pakistan [12]; Trial registration: NCT00682006

2X2 factorial, cluster-RCT.

I = 4867

C = 4874

T = 9741

Four arms

1)4% chlorhexidine solution once daily up to 14 days along with soap and educational messages promoting hand washing.

2) The chlorhexidine solution only and

3) Hand washing only.

Dry cord care

A reduction in NMR (RR = 0·62, 95% CI 0·45–0·85); risk of omphalitis (RR = 0·58, 95% CI 0·41–0·82; No effect of hand washing for both outcomes

Arifeen, 2012/Bangladesh [11], Trial registration: NCT00434408

Community-based RCT.

I = 19,608

C = 9924

T = 29,532

Three arms:

1) Multiple 4% chlorhexidine cleansing

2) Single 4% chlorhexidine cleansing

Dry cord care

NMR = 22·5 per 1000 LB in single chlorhexidine group, 26·6 per 1000 LB among multiple chlorhexidine groups and 28·3 per 1000 LB in dry cord care group.

Mullany L, C,2006/Nepal &Bangladesh [10],

Trial registration: NCT00109616

Cluster-RCT.

I = 4924

C = 5082

T = 10,006

Three arms:

1)4% chlorhexidine,

2) cleansing with soap and water

Dry cord care.

Neonatal mortality was 24% lower in the chlorhexidine group (RR = 0·76, [95% CI 0·55–1·04]) than in the DCC group

Severe omphalitis in chlorhexidine clusters was reduced by 75% (incidence rate ratio 0·25, 95% CI 0·12–0·53.

  1. aI Intervention
  2. bC Control
  3. cT Total
  4. dNMR Neonatal Mortality Rate
  5. eIG Intervention Group
  6. fCG Control Group