Dani Dumitriu, MD, PhD

Clinical Trials

NCT number: NCT04531618

Brief Summary:

The purpose of this study is to compare the mother-infant emotional connection formed during the pandemic in standard care (SC) versus Family Nurture Intervention (FNI) pairs, an evidence-based intervention designed to counteract the adverse effects of maternal-infant disconnection. In prior research on preterm infants in the neonatal intensive care unit (NICU), FNI participants demonstrated increased quality of maternal caregiving behaviors and significant improvements in premature infants' neurodevelopment across multiple domains, including social-relatedness and attention problems. Goals of FNI include assisting mothers in providing appropriate types of stimulation for their babies that are important for social, emotional, and neurobehavioral development as well as reducing stress physiology in both mother and infant. Data gathered in this study will help the investigators learn more about the underlying mechanisms that take place during mother-infant interactions and examine how these play a role in setting the infant up for the best neurodevelopmental trajectory. Intervention will be conducted electronically both in the Well Baby Nursery (WBN) and at home over the following 4 months. Assessments will consist of videos of mother-infant interactions at the time of each intervention session, and pediatrician-led follow-up surveys conducted in the linked Institutional Review Board-approved study.

Detailed Description:

Mother-infant interactions, which are well-established to strongly influence long-term neurodevelopmental outcomes, are at particular risk during the pandemic, both due to maternal stress, as well as to changes in health care policies leading to decreased interaction with healthcare providers during the immediate postpartum period. In order to minimize risk of severe acute respiratory syndrome (SARS)-CoV-2 transmission, nurses and physicians in the WBN have minimized entry and exit into patient rooms, and new moms are discharged on average one day early. In addition to psychological stress, there are also currently unknown risks to the neonates born to mothers with SARS-CoV-2 infections at various points in their pregnancy. Although viral transmission itself seems unlikely, it is currently completely unknown if secondary effects will be observed. In the case of maternal HIV infection, it is now well established that even when vertical transmission does not occur, there are negative consequences to neurodevelopmental outcomes of these exposed children. It is therefore imperative to develop preventative strategies that protect newborns and set them on the path of optimal neurodevelopment. As mother-infant nurturing interactions are known to be the most crucial ingredient in optimal neurodevelopmental trajectories, the goal of the investigators is to test the hypothesis that an intervention focused on promoting mother-infant emotional connection in the neonatal period will lead to long-term benefit and prevention of deleterious effects of the COVID-19 pandemic. The investigators will use FNI, an intervention specifically developed to enhance mother-infant emotional connection through facilitated mother-infant interactions, emotional exchanges and mutual calming sessions. Some of the facilitated interactions include: interactive touch with deep emotional expression and vocal soothing, sustained reciprocal olfactory exposure, family practice in comforting, and skin-to-skin holding. Previously at CUIMC, an RCT investigated the effects of FNI in NICU infants. Infants who received FNI showed significant increases in electroencephalogram (EEG) power, a measure of brain activity, near term age compared with those who receive Standard Care (SC). Increased EEG power has previously been shown to be associated with improved cognitive development, as measured by the Bayley Scales of Infant and Toddler Development (BSID-III). Within the group of children who scored above 85 on the Bayley-III (1 standard deviation below the mean or higher), FNI infants scored significantly higher on the BSID-III Cognitive and Language scales compared to SC infants. Additionally, FNI infants had lower risk for autism spectrum disorder (ASD) as measured by the Modified Checklist of Autism for Toddlers (M-CHAT), an early ASD screening questionnaire. FNI infants also displayed significantly lower levels of EEG coherence (1-18 Hz) largely within and between frontal regions. This finding suggests that FNI may accelerate brain maturation particularly in frontal brain regions, which are involved in regulation of attention, cognition, and emotion. Taken together, the first RCT of FNI is strongly suggestive of neurodevelopmental benefit.

Purpose/aims: The COVID-19 pandemic has made precautions necessary in the Well Baby Nursery that result in maternal stress which is known to impair mother-infant bonding, which is well-established to be critical for positive long-term neurodevelopmental and behavioral outcomes. The investigators will be conducting a randomized controlled trial (RCT) of Family Nurture Intervention (FNI) in the Morgan Stanley Children's Hospital (MSCH) Well Baby Nursery (WBN) at Columbia University Irving Medical Center (CUIMC). The RCT will compare neurodevelopmental and socio-emotional outcomes of the current standard of care (SC) during the COVID-19 pandemic with Family Nurture Intervention (FNI) conducted via telemedicine.