A pre-post quasi-experimental study, nested within a large stepped-wedged randomized control trial to evaluate the effectiveness of quality improvement interventions in 12 public hospitals of Nepal[24], was conducted among all births occurring in these hospitals between the 1 July 2017 and the 17 October 2018 with first four months as pre-intervention period and remaining twelve months as intervention period.
Based on the readiness of health facilities, newborn care in health facilities is classified into three levels- primary or basic neonatal level care at primary health care centers (level 1), secondary level care at special newborn care unit (SNCU) (level 2) and tertiary level care at neonatal intensive care unit (NICU) (level 3) [25]. As of November 2017, the FNC service package was implemented in all the public hospitals across the country. Under this package, central Ministry of Health and Population reimburse the costs to public hospitals which provide free newborn care package based on the level of newborn care. The amount of reimbursement to each hospital per sick newborn is given based on the package of free newborn implemented (Table 1). The hospital which implement package A receive 9.6 USD per sick newborn admitted. The package A consists of basic sick newborn care. The hospital which implement package B receive 19.2 USD per sick newborn admitted. The package B consists of specialized newborn care. The hospital which implement package C receive 48.0 USD per sick newborn admitted. The package C consists of neonatal intensive care.
Setting
The hospitals included within the study were government-funded referral centers for maternal and newborn care, each with more than 1,000 deliveries per year. These hospitals varied in terms of service coverage and were diverse in relation to ethnicity, language, and religion. Four of the hospitals were high-volume (>8,000 deliveries a year), four medium-volume (>3,000 deliveries a year), and the remaining four low-volume (>1,000 deliveries a year) hospitals. The low volume hospitals (Bardiya, Pyuthan, Nuwakot, and Nawalparasi) did not have specialized care services for sick newborn. The high-volume hospitals (Koshi Zonal, Bharatpur, Lumbini Zonal, and Bheri Zonal) and medium-volume hospitals (Western Regional, Rapti Sub-Regional, Mid-Western Regional, and Seti Zonal) provided specialized newborn care services. The SNCUs and NICUs were led by the pediatricians while in low volume hospitals, sick newborns were managed by medical doctors at the pediatric unit.
Participants
All babies delivered in the study period who were admitted for sick newborn care were included in this study. Births with missing data on the cost of care were excluded from the analyses.
Variables and outcomes
Out-of-pocket expenditure (OOPE) was defined as a fee made by an individual for a consultation with a health professional, an investigation or procedure, medicines, supplies and laboratory tests.
Neonatal morbidity: Sick newborns were classified having any of the following diagnoses[26]:
- Hypoxic Ischemic Encephalopathy (HIE): Syndrome of abnormal neurological behavior in the neonate, which is frequently associated with multi-system dysfunction and follows severe injury before or during delivery.
- Neonatal sepsis (NNS): Clinical signs of severe bacterial infection, with a blood culture positive for a pathogenic organism.
- Hyperbilirubinemia (HBL): Babies with total Serum Bilirubin (TSB) increasing by >5 mg/dl/day or 0.5 mg/dl/hour, TSB>15 mg/dl, conjugated serum bilirubin > 2 mg/dl.
- Meconium aspiration syndrome (MAS): Breathing problems that a newborn baby may have when there are no other causes, and the baby has passed meconium (stool) into the amniotic fluid during labour or delivery.
- Respiratory Distress Syndrome (RDS): Neonate with signs of respiratory distress-cyanosis, tachypnoea (>60/min, shallow, rapid), grunting (delayed expiration maintains Functional residual capacity), retraction (Subcostal, sub-sternal, intercostal), flaring (50% airway resist in nose& pharynx).
Others included low birth weight, shoulder dystocia, hypoglycemia, congenital malformation, etc.
Data collection and management
Data were collected through a data surveillance system established in all the hospitals. For obstetric variables, data were extracted from the maternity registers and medical records by trained data collectors using a data retrieval form. For sociodemographic variables and OOPE, data were collected by the data collectors at the respective hospitals through semi-structured interviews with mothers before discharge. Completed forms were then assessed for completeness and accuracy by a data coordinator at the hospitals. Data were then entered into the data base by the data entry and management team using the Census and Survey Processing System (CSPro).
Statistical analysis
The cleaned data were exported into Statistical Package for Social Sciences (SPSS) version 23 for analysis. Descriptive statistics were presented with mean, standard deviation (SD), median, interquartile range (IQR), frequency and percentage. Logistic regression was used to compare background characteristics of the sick newborns and the Mann-Whitney test was applied for comparing the cost of care between the groups. Logistic regression was used to explore the association between sick newborns and expenditure for services received. P-value < 0.05 was considered to be statistically significant. Missing data were excluded from the analyses.
Ethical approval and consent
Written informed consent was obtained from the mothers before inclusion in the study and confidentiality was maintained. The study was approved by Ethical Review Board of Nepal Health Research Council (reference number 26-2017).