The Study
Studying psychosocial and physiological factors related to prematurity invites the Psychology – Medicine interdisciplinary collaboration because: a) premature infants possess behavioral characteristics and have neurological immaturity that may contribute in making them difficult interactive partners (Singer, 2003) and increase their health risks (Javorka, 2017); and b) a steady increase in the neonatal survival rates since the advent of modern intensive care for the preterm infant has been related to a growing concern for preterm infants’ developmental outcome and quality of life (Forcada-Guex, 2006).
Women from low SES and in low-income countries are disproportionally affected by preterm delivery, perinatal depression / anxiety, and lack access to mental health care. This results in economic and social hardships that affect individuals, families and society as a whole, furthering the cycle of poverty and health inequities (Prom, 2022). The implications of this study may highlight the need to advance the debate about the responsibility of society to counteract health inequalities (M’hamdi, 2017) and to interrupt the pattern of intergenerational mental illness and suffering (Prom, 2022). This is important because the perinatal mental health literature has focused on individual women as the main agent for change while social determinants of mental health, such as poverty, are of critical importance for women in the perinatal period (Howard & Khalifeh, 2020). At the economic level, identification of early risk factors for the development of preterm infants may has implications for policymakers since preterm infants incur higher early intervention costs (Clements, 2007).
Main Purpose
The main aim of this study is to investigate the association of certain psychosocial and biological factors across the first year of life of preterm infants’ development, with focus on low socio-economic status families. Thus, we plan to accomplish the following two objectives:
Objective 1: To explore the way psychosocial factors, such as maternal mental health, maternal perception of infant’s intersubjectivity and attachment, across the first year of preterm birth are related with infants’ emotional and cognitive development at 9 months (corrected age). Further, we will explore whether this association varies between infants from low and high SES. In addition, we will investigate whether other characteristics (family functioning, perceived social support and dyadic coping) may be related to these associations and if these characteristics can moderate for the risks posed by low socio-economic status,
Objective 2: To assess the way physiological factors, such as autonomic nervous system maturation, measured according to heart rate variability, is associated with premature infants’ emotional and cognitive development at 9 months (corrected age) and whether this association varies between low and high SES. Further, we will explore whether maternal derived-melatonin through breastfeeding intervenes this association.
Timeline of the ProMote Study
Kατά την Α φάση της μελέτης ProMote, δηλαδή αμέσως μετά τη γέννηση του νεογνού, θα γίνει η αξιολόγηση συγκεκριμένων ψυχοκοινωνικών και βιολογικών παραγόντων. Πιο συγκεκριμένα, θα αξιολογηθούν οι εξής ψυχοκοινωνικοί παράγοντες: μητρική κατάθλιψη, μητρικό άγχος, αντιλαμβανόμενη κοινωνική υποστήριξη, οικογενειακή λειτουργικότητα και δυαδική αντιμετώπιση του στρες. Επίσης, κατά τη γέννηση του βρέφους θα γίνει αξιολόγηση παραγόντων που σχετίζονται με το κοινωνικο-οικονομικό επίπεδο της οικογένειας. Παράλληλα, κατά την Α φάση της μελέτης, θα γίνει αξιολόγηση της συγκέντρωσης μελατονίνης στο μητρικό γάλα, σε δείγμα αίματος των νεογνών και του ομφάλιου λώρου και θα πραγματοποιηθούν μετρήσεις του νεογνικού και του μητρικού ECG.
Κατά τη Β φάση της μελέτης ProMote, δηλαδή στους έξι (6) μήνες ζωής του βρέφους, οι ψυχοκοινωνικοί παράγοντες που θα αξιολογηθούν είναι οι εξής: μητρική κατάθλιψη, μητρικό άγχος, αντιλαμβανόμενη κοινωνική υποστήριξη, οικογενειακή λειτουργικότητα, δυαδική αντιμετώπιση του στρες και διυποκειμενικότητα.
Κατά τη Γ φάση της μελέτης ProMote, δηλαδή στους 9 μήνες ζωής των πρόωρων βρεφών (διορθωμένη ηλικία), θα πραγματοποιηθεί η αξιολόγηση της κοινωνικής και γνωστικής ανάπτυξη των βρεφών μέσω της χορήγησης του Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley, 2006). Επίσης, στους εννέα (9) μήνες ζωής του βρέφους, οι ψυχοκοινωνικοί παράγοντες που θα αξιολογηθούν είναι οι εξής: μητρική κατάθλιψη, μητρικό άγχος, αντιλαμβανόμενη κοινωνική υποστήριξη, οικογενειακή λειτουργικότητα, δυαδική αντιμετώπιση του στρες και δεσμός. Τέλος, μετρήσεις του βρεφικού και του μητρικού ECG θα πραγματοποιηθούν στους 9 μήνες ζωής του βρέφους.
Ολοκλήρωση της διαδικασίας εύρεσης υποκειμένων και της συλλογής δεδομένων ψυχοκοινωνικών παραγόντων της μελέτης ProMote
Ολοκλήρωση συλλογής βιολογικών δειγμάτων της Α φάσης της μελέτης
New knowledge to be acquired by the ProMote study
The proposed study is novel in the following ways:
(1) The role of melatonin for preterm infant development is unclear (Tauman, 2002) and under-investigated. Towards this direction, we aim to investigate the role of melatonin on infant development through a suspected multifactorial early developmental pathway combining psychosocial and biological factors;
(2) The proposed study on determinants of premature infant development is longitudinally. Appropriate longitudinal studies for premature infants are scarce. In order to fully recognize the difficulties of children born preterm, it is important to follow them individually, through several developmental stages (Jansen, 2021). Longitudinal studies should be pursued in forthcoming years to deepen our understanding of the pathways leading to heightened risk for adverse developmental outcomes in preterm infants (Provenzi, 2017);
(3)This is a multi-method study including physiological and hormone measures, one observational instrument and self-report validated questionnaires. Using multiple outcome measures in infant research is one way to increase rigor, and at the same time, enable us to more accurately interpret our data (LoBue, 2020);
(4) Evidence on premature infant development is limited in Greece (Koutra, 2012). To the best of our knowledge the proposed study will be the first of this kind in Crete, Greece at a time after the financial crisis and in the course of the pandemic. This is important because the financial crisis of the last decade has increased the number of people living in extreme poverty in Greece and led to partial operation of mental health services (Papadakaki, 2021; Tsobanoglou, 2014; Giannopoulou & Tsobanoglou, 2020). What is more, the pandemic increased income inequalities (Vavoura & Vavouras, 2022) and affected adversely the mental health of Greeks (Parlapani, 2020; Vatavali, 2020). In Crete, poverty and mental health problems, especially for women, are prevalent and interconnected issues. Multiproblem families have been said to be on the rise (Papadakaki, 2021). Further, preterm births constitute a major public health issue in Greece (Vlachadis, 2013). Preterm birth rate has increased fourfold in the past two
Approvals of the ProMote study by Research Ethics Committees
The protocol of ProMote study has been approved by the Research Ethics Committee of the University of Crete (numbers and dates of decision: 103/22.09.2023, 158/15.12.2023 and 38/ 15.02.2024) and by the Scientific Council, according to the positive recommendation of the Working Group of the Ethics Committee, and the Board of Directors of the General University Hospital of Heraklion (reference number: 26636/2.10.2023 and 35546/23.10.2023).