dc.description.abstract |
Background:
The Antenatal Corticosteroid Trial (ACT) assessed the fe
asibility, effectiveness, and safety of a multifaceted
intervention to increase the use of antenatal corticosteroids
(ACS) in mothers at risk of preterm birth at all levels of care
in low and middle-income countries. The intervention effectively increased the use of ACS but had no overall impact on
neonatal mortality in the targeted <5
th
percentile birth weight infants. Being in the intervention clusters was also
associated with an overall increase in neonatal deaths. We
sought to explore plausible pathways through which this
intervention increased neonatal mortality.
Methods:
We conducted secondary analyses to assess site differ
ences in outcome and potential explanations for the
differences in outcomes if found. By site, and in the interventio
n and control clusters, we evaluated characteristics of the
mothers and care systems, the proportion of the <5
th
percentile infants and the overall population that received ACS,
the rates of possible severe bacterial infection (pSBI), determined from clinical signs, and neonatal mortality rates.
Results:
There were substantial differences between the sites in both participant and health system characteristics, with
Guatemala and Argentina generally having the highest levels
of care. In some sites there were substantial differences in
the health system characteristics between the intervention a
nd control clusters. The increase in ACS in the intervention
clusters was similar among the sites. While overall,
there was no difference in neonatal mortality among <5
th
percentile
births between the intervention and control clusters, Guatem
ala and Pakistan both had significant reductions in neonatal
mortality in the <5
th
percentile infants in the interv
ention clusters. The improvement in neonatal mortality in the
Guatemalan site in the <5
th
percentile infants was associated with a higher level of care at the site and an
improvement in care in the intervention clusters. There wa
s a significant increase overall in neonatal mortality in
the intervention clusters compared to the control. Across si
tes, this increase in neonatal mortality was statistically
significant and most apparent in the African sites. This increase in neonatal mortality was accompanied by a
significant increase in pSBI in the African sitesConclusions:
The improvement in neonatal mortality in the Guatemalan site in the <5
th
percentile infants was
associated with a higher level of care and an improvement in care in the intervention clusters. The increase in
neonatal mortality in the intervention clusters across
all sites was largely driven by the poorer outcomes in the
African sites, which also had an increase in pSBI in the in
tervention clusters. We emphasize that these results
come from secondary analyses. Additional prospective s
tudies are needed to assess the effectiveness and safety
of ACS on neonatal health in low resource settings. |
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