In recent decades, research in crisis setting has been evolving and progressing towards a more interdisciplinary approach (Bergman-Rosamond, A et al., 2020). As the world advances and becomes more and more interconnected, the effects of the multilevel systems that affect health outcomes ought to be addressed. Indeed, crises cannot be managed as events occurring in silos, rather they are a manifestation of the complex web of social, political, economic, and health systems which affect lives and health outcomes.
For the past few years, Lebanon has been an unfortunate perfect representation of a country being faced with multiple simultaneous crises. Economically, the financial crisis which started in late 2019 is still ongoing and is manifesting in the depreciation of the local currency at more than 90% its value, in an increasingly soaring inflation at more than 200%, and in significant restrictions on banking transactions and funds use (Blair E, 2022). From a political perspective, since 2019, Lebanon has been gripped by a national revolution, political unrest, presidential vacuum, and widespread corruption across multiple public sectors (Ibrahim, A., & Jawhar, S., 2023). From a public perspective, lack of essential services from electricity to fuel, to medications, has severely impacted the lives of Lebanon’s residents for the past several years (Doctors Without Borders, 2021).
Lebanon’s infrastructure, particularly healthcare infrastructure, has also been further strained by the impact of the COVID-19 pandemic, the financial challenges, and the catastrophic August 2020 Beirut port explosion. The healthcare crisis is multifaceted and has been characterized by staffing shortage, closure of medical centers (Bou Sanayeh, E., El Chamieh, C, 2023), shortage of medications, and shortage of instruments and lab kits (Nassar M., et al., 2023) to name a few.
In this context, exploring the impact of crises on vulnerable groups becomes imperative. Preterm babies and their parents are already at a disadvantage with a need for medical, social, and emotional support especially during the critical 1000 days for them to reach their developmental potential. Several risk factors have been identified for preterm birth. Some of the main determinants of preterm birth are social disadvantage and low socioeconomic conditions (Abbot A, 2015; Sebayang S.K et al., 2012; Harrison, M.S. & Goldenberg R.L., 2016), lower mothers’ educational status, and higher maternal anxiety and stress in pregnancy (Dolatian M., et al., 2013). In addition, studies have revealed that preterm birth is more common in mothers who suffer from anxiety and depression (Sharifi N., et al., 2018; Rahman, A, et al., 2019; Goldenberg R.L., 2016; Strange, L.B., et al., 2009). Other studies have also shown that lower income is among the structural factors which affect preterm birth, and perceived stress, perceived social support and financial support are also associated with preterm birth (Goldenberg R.L., 2016; Strange, L.B., et al., 2009; Dolatian, M., et al., 2014; Kumar,S., et al., 2017; Chiavarini, M, et al., 2012).
In Lebanon, the deterioration of the healthcare and economic systems is expected to have had large negative consequences on this vulnerable group. Indeed, economic disadvantage is not only a risk factor of preterm birth, but also of other important developmental outcomes, including cognitive functioning, and social, behavioral, and emotional development (Scharf, R.J., et al., 2016; McCoy DC, 2015; Rijlaarsdam J, et al, 2013).
Cohort studies are distinctive in supporting our understanding of child development, particularly in contexts like Lebanon, allowing for observation and follow-up for an extended period, capturing dynamic changes and long-term outcomes. Lebanon, with its several concurrent crises, thus presents an important case for studying the impact of the social environment on vulnerable preterm infants' developmental outcomes.
Objectives:
We originally aimed at building a cohort of 50 full term babies and their mothers and 50 full term babies and their mothers, recruited at birth, and followed up for up to 9-12 months post birth. The objectives of this cohort were to examine the association between social determinants and preterm birth, and to examine the association between preterm birth and developmental outcomes of infants. In parallel with the launch and establishment of the cohort, Lebanon’s rapid socio-political changes and complex financial and healthcare challenges began unfolding.
In this report, the objectives are to examine the feasibility of building a prospective mother and child cohort and on examining the challenges and barriers of conducting such research in a crisis ridden and low resource setting.
Population:
The study population of the originally planned cohort consisted of babies born before 37 weeks of gestation at the American University of Beirut Medical Center (AUBMC) and their mothers, and a comparator group of babies born at 37 weeks of gestation and above also born at AUBMC.
Based on a review of the literature of previous studies, we estimated the sample size needed to be able to reject the null hypothesis that preterm children and full-term children will have similar scores on the developmental assessment. Thus, the original target sample was 50 full term babies and 50 preterm babies and their mothers to support detecting a difference in the mean scores on the developmental assessment between the two groups with an effect size of 0.6 and a probability of 0.85.
Nine months after recruitment was launched at AUBMC, and to support recruitment efforts, particularly for preterm infants, another center, Keserwan Medical Center (KMC), was added as a recruitment center. A year after recruitment launched, a third center, Bahman Hospital was also added, to both support recruitment efforts, and to extend the sampling frame to those of lower socioeconomic levels. The inclusion and exclusion criteria were the same across the different centers. AUBMC serves a diverse population of patients, including the more central and urban residents of the capital Beirut, as well as employees of the institution who benefit from the HIP and who have diverse socioeconomic levels, in addition to the outpatient clinic which specializes in offering services for residents with limited financial or healthcare coverage resources. KMC is located to the north of Lebanon and serves residents who are further from the capital. Bahman offers medical care to residents with limited resources for medical care support and financial means. The detailed reasons underlying the addition of the two centers will be discussed further along in this paper.
Non-Lebanese and those who are not permanent residents in Lebanon were excluded as these are likely to be the most mobile thus limiting the possibility of follow up and leading to high attrition rates. Also excluded were infants with major congenital anomalies (Trisomy 13, Trisomy 18, Holoprosencephaly, Anencephaly, Encephalocele) who exhibit severely impaired communication as they would be unable to undergo the needed developmental assessment during follow-up visits. Finally, babies who passed away in the Neonatal Intensive Care Unit (NICU) were excluded.
After the inclusion of the two additional sites, the target sample was increased to 80 full term babies and 80 preterm babies and their mothers. The Type I error probability associated with this test of this null hypothesis is 0.05.
Design:
The original cohort was a single center prospective cohort. Recruitment at AUBMC was launched in September 2021 and was originally planned to be for one year with data collection done at three time points: At recruitment in the postpartum unit after birth, at 4-6 months post birth, and at 9-12 months post birth.
Nine months after recruitment, as explained prior, the cohort expanded to a multi-center cohort. Recruitment at KMC launched in June 2022, and launched at Bahman Hospital in October 2022.
The project has been approved by the Institutional Review Board (IRB) of all participating centers and informed consent from the mothers is secured upon recruitment. At the time of continuing review, permission was granted from the Institutional Review Board to extend recruitment at all sites considering the challenges being faced particularly regarding the decreasing number of admissions at the hospitals.