Elsevier

The Lancet

Volume 381, Issue 9884, 22–28 June 2013, Pages 2184-2192
The Lancet

Articles
Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial

https://doi.org/10.1016/S0140-6736(13)60095-1Get rights and content

Summary

Background

In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices.

Methods

The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337.

Findings

16 168 (99%) of 16 329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15 619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96–1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81–1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17–1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03–1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05–1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12–1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02–1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07–1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85–2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27–2·13; p<0·0001), exclusive breastfeeding for 26–32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04–1·16; p=0·001), and baby sleeping under bednet for 8–56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03–1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75–1·12; p=0·405).

Interpretation

The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5–18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions.

Funding

WHO, Bill & Melinda Gates Foundation, and UK Department for International Development.

Introduction

Every year 3·3 million babies die within the first 28 days of life (the newborn or neonatal period); newborn deaths account for 41% of all child deaths in developing countries.1, 2 Another 3·2 million babies are stillborn.3 Effective interventions could prevent most of these deaths.4 The challenge is to identify strategies that can be implemented feasibly in the short term to ensure that newborn babies have access to these life-saving interventions. In 2009, WHO and UNICEF issued a joint statement calling on all governments in low-income and middle-income countries to implement home visits for newborn babies.5 In particular, they recommend three visits during the first week of life to promote essential newborn care, examine newborn babies for danger signs and treat or refer them as appropriate, and counsel the family about danger signs and the importance of prompt care-seeking for the newborn baby.

This strategy was based on results from four proof-of-principle studies in south Asia (appendix pp 1–2) showing that home visits for promotion of essential newborn-care practices and treatment or referral of sick babies can reduce the neonatal mortality rate (NMR) by 30–60%. These studies were a non-randomised comparison in Gadchiroli, India,6, 7 cluster randomised controlled trials in Shivgarh, India,8 and Sylhet, Bangladesh,9 and a pilot study in Hala, Pakistan.10 Since the joint statement was issued, effects on NMR have been reported in three cluster randomised controlled trials of interventions delivered in a programme setting that included home visits (appendix pp 1–2). The results of these trials in south Asia showed substantially lower reductions in NMR than did the proof-of principle trials: Projahnmo2 in Mirzapur, Bangladesh11 (13% reduction), Hala, Pakistan12 (15% reduction), and an assessment of the integrated management of the newborn and childhood illnesses programme in Haryana, India13 (9% reduction).

We present findings from the Newhints14 cluster randomised controlled trial, which was designed to test the effect of the home-visits strategy in Ghana delivered by the existing community-based surveillance volunteers (CBSVs). The underlying hypotheses were that CBSVs could be trained to make home visits during pregnancy and the first week of life to promote essential newborn-care practices and assess and refer sick newborn babies, they would achieve a high coverage of the Newhints home visits, these visits would lead to improved essential newborn-care practices and increased access to care for sick newborn babies, and this strategy would save newborn lives. The primary objectives were therefore to assess the effect of the Newhints intervention on all-cause NMR, and essential newborn-care practices including care-seeking.

Section snippets

Methods

Newhints was a cluster randomised controlled trial; the clusters were CBSV supervisory zones. It was undertaken in seven predominantly rural districts in the Brong Ahafo Region, Ghana: Kintampo North, Kintampo South, Nkoranza North, Nkoranza South, Tain, Techiman, and Wenchi. The trial area comprised 98 supervisory zones, each with eight to 12 CBSVs; 49 zones were randomly assigned to the Newhints intervention and 49 to the control group (appendix p 3). Detailed information about the methods

Results

Figure 2 shows the trial profile. 98 zones were randomly assigned to Newhints and control. 19 981 women were identified as being pregnant from Nov 1, 2008, the start of the trial, and 1372 of these were still pregnant at the end of the study on Dec 31, 2009. There were 18 609 eligible pregnancies, 9435 in the 49 control zones and 9174 in the 49 Newhints zones. Three groups of pregnancies were not included in the analysis of NMR: 908 (5%) women were lost to follow-up during pregnancy; 1216 (7%)

Discussion

Newhints achieved an 8% reduction (95% CI −12 to 25; p=0·405) in overall NMR (table 3). Figure 4 and the panel show this finding in context with other evidence. Figure 4 shows that this small reduction is similar to the small reductions in NMR achieved in the other three trials to test the effect of the home visit strategy delivered in a programme setting. The summary estimate represents an overall reduction in NMR of 12% (5 to 18; figure 4). Because there is no suggestion of any heterogeneity

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