Study setting, design and period
This is a prospective cohort study, nested within a large-scale cluster randomized control trial which evaluated the Helping Babies Breathe Quality Improvement package in 12 public hospitals of Nepal[16, 17]. The hospitals are mapped in Figure 1. These hospitals are referral centres which provide obstetric, neonatal and paediatric services. The annual number of deliveries in each hospital ranged from 1,194 to 11,318. All these hospitals provided comprehensive obstetric and neonatal care services along with sick newborn care services (Additional file 1). This paper presents data from a period of 14 months from July 2017 to August 2018.
Study population-All the newborns who were born at the participating hospitals during the study period were eligible for the study. The newborns with consenting parents were enrolled in the study. All the newborns with signs of clinical infection or positive septic screening with birth weight 1500 gram or more and/or gestational age 32 weeks or more were treated as ‘cases’. All other newborns were treated as referent or comparison population.
Study size – All eligible cases consenting for participation were included in the study. A total of 60,400 mothers, based on the sample size required to evaluate the effect of quality improvement package for the primary study was taken for this study.
Data sources/measurement- Information on newborn were obtained from data collectors who were assigned to the maternity ward in each hospital. A data retrieval form was used to extract clinical information on mothers and newborn from the patient records and register. A semi-structured interview with mothers were conducted to assess information on their socio-demographic characteristics and antenatal care.
Data management and statistical methods- After the completion of recording and interviews, forms were assessed by the data coordinator in each site for completeness. To ensure the accuracy of the data collected, 10% of the mothers’ information were recollected by the data coordinator. At the end of each day, the information sheets were indexed by the data coordinator. Every week completed forms were sealed in an opaque envelope and sent to the Kathmandu office for further data management. In the Kathmandu office, these forms were reassessed for completeness and open-ended questions were recoded. Data entry was done in CS pro (Census and Survey Processing System) database and five percent of data were re-entered to assess the accuracy of data entry. Every month the data were entered into a data entry platform, CS pro. Finally, the data were exported to SPSS (Statistical Package for the Social Sciences) for statistical analysis.
To ensure the privacy and safety of the data, the exported data were stored in an external hard drive. Prior to data analysis, anonymization and removal of location of the participants was ensured. All hard copies of information sheets were indexed and stored as per the ethical guideline.
Study variables
Socio-demographic, maternal, obstetric and neonatal characteristics were collected through data extraction and semi-structured interviews.
Maternal age- Maternal age was categorized as less than 20 years, 20-35 years and 35 years and above.
Maternal education- Mothers who are illiterate or have received education through informal trainings other than in schools were categorised as having 'no formal education' while those who had gone to school for education were considered as having 'formal education'.
Ethnicity- was categorized as Dalit, Janjati, Madhesi, Muslim, Chettri/Brahmin, and other castes based on hierarchical caste system of Nepal[18]. Ethnicity was categorized as disadvantageous group (Dalit, Janjati and Muslim) and relatively advantageous group (Madhesi, Chettri/Brahmin and other castes).
Mothers smoking status - Smokers were those who had a history of smoking during or before pregnancy. Non-smokers were those who never smoked in their lifetime.
Indoor tobacco smoke- Environmental tobacco smoke (ETS), also referred to as second hand smoke, is a mixture of exhaled mainstream smoke (MS) and side stream smoke (SS) released from the smouldering tobacco product[19],
Parity- Mothers who had no previous births (nulliparity), at least one or more previous birth (primiparity and multiparity),
Antenatal check-up- Mothers who received antenatal care (ANC) check-up from a skilled provider,
Four antenatal check-up– Mothers who received at least four ANC check-ups from a skilled provider or less than four check-ups,
Severe anaemia during pregnancy- Serum haemoglobin less than 7.0 gram/decilitre,
Suspected maternal infections- Mothers who received prophylactic antibiotics for a suspected infection,
Mode of delivery- Mothers who gave birth vaginally or through caesarean section.
Gender of the baby-The sex of the baby as male or female.
Weight of the baby- Birth weight categorized as less than 2500 grams, 2500-4000 grams or 4000 grams and more.
Gestational age– Gestational age is calculated using the last menstrual period and categorized as less than 37 weeks, 37-42 weeks or 42 weeks and more.
Immediate breast feeding- Breast feeding within 1 hour of birth.
Applied antiseptic to umbilical cord stump- Application of antiseptic to the umbilical cord.
Multiple Birth- Mother delivered two or more babies.
Birth asphyxia-Birth asphyxia was defined as APGAR score of less than 6 at 1 minute or/and APGAR score of less than 6 at 5 minutes
Data analysis
The incidence of neonatal infection was calculated with 95% confidence interval (CI) by socio-demographic characteristics (maternal age, maternal education, ethnicity, smoking and indoor pollution), maternal characteristics (parity, antenatal checkup and severe anemia), obstetric and neonatal characteristics (suspected maternal infection, mode of delivery, gender of baby, birth weight, gestational age, breast feeding, applied antiseptic to umbilical cord, multiple birth and birth asphyxia). The variables among the socio-demographic, maternal, obstetric and neonatal characteristics for neonatal infection with 95% CI higher than the comparator group with p<0.05 were included within bi-variate logistic regression. Variables included within the bi-variate analysis with a p-value <0.01 were subsequently included within the multi-variate analysis. Crude odds ratios were calculated from bi-variate analysis and adjusted odds ratio were calculated from multi-variate analysis.
Missing variables were excluded from the analysis.