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Mother-infant Bonding During COVID-19

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ClinicalTrials.gov Identifier: NCT04531618
Recruitment Status : Recruiting
First Posted : August 28, 2020
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Dani Dumitriu, Columbia University

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.

Condition or disease Intervention/treatment Phase
Child Development Mother-Infant Interaction COVID-19 Behavioral: Family Nurture Intervention (FNI) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Promoting Mother-Infant Emotional Connection During the COVID-19 Pandemic: an Randomized Controlled Trial (RCT) of Virtual Family Nurture Intervention
Actual Study Start Date : August 13, 2020
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Family Nurture Intervention (FNI)
Receives a FNI session over Zoom in the Well Baby Nursery and 3 subsequent Zoom sessions over the next 3 months.
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).

No Intervention: Standard of Care (SC)
SC receives the regular standard of care in the Well Baby Nursery and no intervention.



Primary Outcome Measures :
  1. Change in Welch Emotional Connection Score [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The Welch Emotional Connection Screen (WECS) is a validated scale for quantitative assessment of the emotional connection between infant and mother by scoring the interaction of the dyad in four domains: attraction, vocal communication, facial communication, and sensitivity/reciprocity. The domains are scored on a scale from 1.0 to 3.0 in 0.25 point increments, with higher scores indicating stronger emotional connection. In combination with the rating of the four domains, the overall WECS score is classified as "emotionally connected" or "not emotionally connected." A score of "emotionally connected" or "not emotionally connected" is determined by the observers' overall assessment of the emotional connection of the dyad. The WECS will be measured at baseline for both groups, and at each of the 3 subsequent visits by a researcher observing the dyadic interaction during a 5 minute period of face-to-face time. Changes in score from baseline to 3 months will be evaluated for FNI groups.

  2. Change in Maternal Caregiving Behavior Score (Acceptance versus Rejection) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of acceptance versus rejection, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  3. Change in Maternal Caregiving Behavior Score (Sensitivity versus Insensitivity) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of sensitivity versus insensitivity, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  4. Change in Maternal Caregiving Behavior Score (Consideration versus Intrusiveness) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of consideration versus intrusiveness, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  5. Change in Maternal Caregiving Behavior Score (Quality of Physical Contact) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of quality of physical contact, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  6. Change in Maternal Caregiving Behavior Score (Quality of Vocal Contact) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of quality of vocal contact, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  7. Change in Maternal Caregiving Behavior Score (Effectiveness of Response to Baby's Crying) [ Time Frame: Baseline, 1 month, 2 months, 3 months ]
    The quality of caregiving in the domain of effectiveness of response to baby's crying, will be measured on a scale from 1-9, with 9 indicating higher quality caregiving. During each Zoom call, following the mother-infant interaction video but prior to intervention for the FNI group, a recording will be obtained where mother undresses infant, changes diaper, and redresses infant. This video will be scored with an adaption of the Ainsworth System for Rating Maternal Care-Giving Behavior with measures such as sensitivity and intrusiveness.

  8. Right and Left Frontal Mother & Infant EEG Synchrony [ Time Frame: Baseline, Up to 3 days ]
    2 Epilog devices will be put on mother and baby's foreheads for 2 lead EEG recording, left frontal and right frontal. EEG synchrony between mom and baby will be examined for change in synchrony over the course of the first intervention in the nursery.

  9. Heart Rate Variability (HRV) [ Time Frame: Baseline, Up to 3 days ]
    Epilog devices will be used to collect ECG from both mother and infant during the first interaction and intervention in the nursery. Change in synchrony of HRV will be examined over the course of the intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531618


Contacts
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Contact: Dani Dumitriu, MD, PhD 646-774-6255 dani.dumitriu@columbia.edu
Contact: Martha Welch, MD 212-342-4400 mgw13@cumc.columbia.edu

Locations
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United States, New York
Morgan Stanley Children's Hopspital Recruiting
New York, New York, United States, 10032
Contact: Dani Dumitriu, MD, PhD    646-774-6255    dani.dumitriu@columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Dani Dumitriu Columbia University Irving Medical Center
Publications:
Achenbach TM, Rescorla L. Manual for the ASEBA Preschool Forms &Amp; Profiles: an Integrated System of Multi-Informant Assessment. Burlington, VT: ASEBA; 2000.
Als, H. Reading the premature infant. In: Nurturing the Premature Infant: Developmental Interventions in the Neonatal Intensive Care Nursery. New York: Oxford University Press; 1999.
Benasich AA, Thomas JJ. Developmental Disorders of Language. Encyclopedia of Cognitive Science Nadel/Cognitive. 2006.
Dumitriu D, Emeruwa UN, …, Stockwell MS, Gyamfi-Bannerman C. (In press) Outcomes of newborns born to mothers with SARS-CoV-2 infections at a large medical center in New York City. JAMA Pediatrics
Radloff LS. The CES-D Scale: A Self-Report Depression Scale for Research in the General Population. Applied Psychological Measurement. 1977;1(3):385-401.

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Responsible Party: Dani Dumitriu, Assistant Professor of Pediatrics (in Psychiatry), Columbia University
ClinicalTrials.gov Identifier: NCT04531618    
Other Study ID Numbers: AAAT0140
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dani Dumitriu, Columbia University:
Family Nurture Intervention
Emotional Connection