Official Title
Promoting Mother-Infant Emotional Connection During the COVID-19 Pandemic: an Randomized Controlled Trial (RCT) of Virtual Family Nurture Intervention
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.

Child Development
Mother-Infant Interaction

Behavioral: Family Nurture Intervention (FNI)

FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a Nurture Specialist. The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU).

Eligibility Criteria

Inclusion Criteria:

- Mother agrees to participate in a linked study involving additional surveys and

- Newborn born between 37 weeks and 40 weeks and 6 days gestational age

- Newborn is a singleton

- Mother can speak English or Spanish

Exclusion Criteria:

- Newborn born at less than 37 weeks and 0 days gestational age

- Newborn born at more than 40 weeks and 6 days gestational age

- Infant's attending physician does not recommend enrollment in the study based on
newborn health concerns or diagnoses, or based on concern regarding maternal history
of maternal substance abuse, severe psychiatric illness or psychosis

- Congenital, cardiac, or chromosomal anomalies requiring special infant care beyond
routine testing based on prenatal concerns (e.g. postnatal ultrasound necessary for
prenatal ultrasound findings of hydronephrosis would not exclude newborn, but newborn
with known Trisomy 21 would)

- Mother and/or infant has a medical condition that precludes intervention components

- Newborn is a twin or other multiple at birth

- Mother is unwilling to place wearable electrophysiological recording devices on
herself or her newborn

- Mother is unwilling to be video recorded or to give consent for videos/photographs
(video stills)/audio (from the videos) to be used in educational materials, scientific
publications or professional meeting presentations

Eligibility Gender
Eligibility Age
Minimum: 12 Hours ~ Maximum: 72 Hours
United States

Morgan Stanley Children's Hospital
New York, New York, United States

Investigator: Dani Dumitriu, MD, PhD
Contact: 646-774-6255


Dani Dumitriu, MD, PhD

Martha Welch, MD

Dani Dumitriu, Principal Investigator
Columbia University

Columbia University
NCT Number
Family Nurture Intervention
Emotional Connection
MeSH Terms