This study was approved by Ethical Committee of Shahid Beheshti University of Medical Sciences under the reference code IR.SBMU.RETECH.REC.1396.848 and the study methodology conformed to Helsinki Declaration standards as revised in 1989.
All data remained confidential, and participants provided an informed consent prior to taking part in the study.
Participants provided informed consent before taking part in the study.
In addition, participation was entirely voluntary. Participants could opt out of the study at any time, and the decision to leave the study would not affect the conventional quality of newborn care services.
This health system interventional study was performed in the two catchment areas of Tehran Defined Population (TDP). TDP includes two areas, intervention and control, which form a defined population representative of Tehran [9, 10].
The intervention areas include 10000 families, 40000 individuals, under the coverage of health services provided by 10 UHCs in 10 municipality districts of the total 22 districts in Tehran. These ten districts consist of two districts from each of the five socioeconomic regions of the city, including north, east, center, west, and south, according to the Tehran Urban Health Equity Assessment and Response Tool study (Urban HEART) .
The control areas are the neighboring areas of the intervention areas, as presented in Fig. 1. The control areas include almost 20000 families, 80000 individuals.
Newborn care organization in Iran
Both public and private sector provide newborn care services in Iran:
a. The public sector
Like all other Iran cities, NBC and screening tests in Tehran are available in the public sector for all newborns in UHCs for free of charge. All newborns need to complete at least 17 NBCVs, which start from the third day after birth to 72 months. This study's focus is on the first three NBCVs, which have recently been added to NBC's schedule, which are to be performed in the first two months after birth. According to the national guideline, the first visit should be performed in the first 3–5 days of life, the second in 14–15 days, and the third in 30–45 days. The guideline of Iran is consistent with the World Health Organization recommendations on postnatal care of mother and newborn [12, 13]. The main components of NBC include assessment of the general appearance of the newborn, neonatal jaundice, weight, height, head circumference, vision, and developmental milestones; immunization; iron and folic acid supplementation; and counseling about breastfeeding, nutrition, maternal and neonatal hygiene, and family planning . Screening tests are mandatory and should be carried out three to five days after birth. The tests include screening for phenylketonuria, congenital hypothyroidism, and glucose-6-phosphate-dehydrogenase deficiency. Screening tests of newborns who require hospitalization are carried out in the hospitals . Midwifery graduates provide NBC in the UHCs. Newborns are referred to the attending general practitioners in the UHCs in cases of warning signs such as low birth weight, jaundice, infection, poor milk sucking, cyanosis, craniosynostosis, and not reaching the developmental milestones. The general practitioners then refer newborns to pediatricians if needed . It is noticeable that the first dose of oral poliomyelitis, hepatitis B virus; and BCG vaccines were administered for neonates at hospital at the time of discharge.
b. The private sector
Newborns could receive NBC services from the private sector at the pediatricians' office and the hospitals' pediatric clinics, for which they will be charged. Laboratories of hospitals or private laboratories also provide screening tests. The out-of-pocket costs vary based on the type of medical insurance.
Healthcare providers in the private sector usually follow the national guidelines of NBC in terms of the schedule and the treatment measures; however, they do not emphasize prevention aspects, supporting breastfeeding, and maternal education as much as healthcare providers in the public sector.
The intervention included newborn-care-oriented-education and encouraging parents to utilize NBC services.
Healthcare providers in UHCs were assigned verbal education of parents in the intervention group about the role of NBC in improving their newborns' health, based on a pre-prepared passage, which was the same in all the UHCs.
They would also encourage and remind parents to bring their children for newborn care. Mothers in the control group would receive NBC services with the same quality from random midwives in a shared room in the UHC, where less time would be allocated for their education or encouragement.
The inclusion criteria were living in the catchment area for the intervention group and the surrounding neighborhoods for the control group and parents' consent to participate. Newborns who had severe health conditions and therefore were admitted to hospital or needed follow-up by specialists, died in the first two months of life or were lost track of due to reasons like moving out of the covered districts of TDP were excluded.
The census method was used for the selection of both intervention and control groups. The intervention group included all newborns in intervention areas of TDP who were born from November 2017 until August 2018 and were referred to UHCs for mandatory newborn screening tests. The study's control group included all newborns born in the same period in control areas of TDP and were referred to UHCs for newborn screening tests.
Among 4870 (intervention = 1551, control = 3319) newborns included in the study, 33 were excluded from, and finally data of 4837 (intervention = 1544, control = 3293) were analyzed. A more detailed flowchart for sampling is shown in Fig. 2.
Variables and data collection
Variables included parents' sociodemographic characteristics, mothers' age at the time of marriage, number of alive children, type of birth, place of screening tests, time, and place of NBCVs, healthcare providers, and whether families were encouraged to perform NBC while going for the screening tests.
Data were recorded at the time of visits or collected from written medical records.
Frequency, mean, and standard deviation were used to describe the data. We used the chi-Square test for categorized variables. T-test and one-way analysis of variance (ANOVA) test were used to analyze the differences among means of two groups and three groups or more, respectively. Statistical analyses were performed using IBM SPSS Statistics 21. A probability level of less than 0.05 was considered significant.