Clinical trial NCT04233489: Clinical Interventions to Mitigate Neurodevelopmental Risk
Official title: Clinical Interventions to Mitigate Neurodevelopmental Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Child Development
Mother-Infant Interaction
Diabetes Mellitus, Gestational
Keywords: mother-infant dyad
family nurture intervention
emotional connection
synchrony
mother-infant interaction
child development
Diabetes Mellitus, Gestational
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: New York State Psychiatric Institute
First posted: 2020-01-18
Enrollment: 4
Sex: ALL
Minimum age (years): 12
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Family Nurture Intervention (FNI) has been shown to facilitate emotional connection and long-term child developmental progress in the NICU population. It has been theorized that FNI also promotes autonomic co-regulation and physiological synchrony between the mother-child dyad. The goal of the pilot study is to assess how a short one-time FNI session between at-risk mother and child dyads in the Well Baby Nursery (WBN) influences physiological synchrony, emotional connection, and developmental changes both short and long-term.

Detailed description: The long-term objective of this work is to improve cognitive, emotional, and social developmental trajectories in at-risk children. Specially, this pilot study will assess the feasibility of Family Nurture Intervention (FNI) in the neonatal period during the infants' stay in the Well Baby Nursery (WBN) in improving developmental trajectories.

FNI is a family-based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a trained provider. 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 this study, the goal is to extend of the findings of FNI to another population of at risk infants - infants born to mothers suffering from gestational diabetes mellitus (GDM). These infants are generally healthy but at higher risk than controls in developing mild cognitive and motor impairments.

In this pilot phase, infants exposed to GDM and case-matched control infants will both receive FNI: (GDM+FNI and Control+FNI). These two groups will be compared to an already existing protocol and pool of participants who did not receive FNI: (GDM+no FNI and Control+no FNI). This allows the study to evaluate both GDM versus control infants as well as the presence of FNI versus no FNI.

The goal is to pilot the potential role of a short, one-time session of FNI in promoting neurodevelopment among an at-risk wellbaby nursery population. This will be achieved by comparing developmental milestones, such as cognitive and motor development, memory, attention, and emotion regulation at 6 and 15 months, between participants who received the FNI and those who did not. Another goal is to elucidate the role FNI has on autonomic co-regulation and mother-infant synchrony through physiological recordings during the FNI session in the WBN.

Eligibility criteria: Inclusion Criteria:

* Medically healthy mothers with and without diabetes (type 1, type 2, or gestational) and their infants
* Infants with gestational age between 37 0/7 and 40 6/7
* APGAR score above 7 five minutes after birth
* Infants between 12-72 hours of life at time of the study
* Mothers between 18-50 years old

Exclusion Criteria:

* Infants with gestational age below 37 0/7 or above 40 6/7
* Infant requiring resuscitation at birth
* Infant admitted to NICU
* Prenatal exposures to psychiatric medications, alcohol, recreational drug use, or smoking
* HIV-positive mother
* Mother with psychiatric diagnosis
* Infant with genetic disorder

Primary outcomes:
measure: Change in Welch Emotional Connection Score
timeFrame: Baseline and 15-months of age
measure: Change in heart rhythm synchrony
timeFrame: Baseline
measure: Change in Social-Emotional Questionnaire (ASQ-SE) Score
timeFrame: 6 months (over the phone) and 15 months (in person)
measure: Change in Ages and Stages questionnaire (ASQ-3) Score
timeFrame: 6 months (over the phone) and 15 months (in person)
measure: Change in Brief Infant Toddler Social Emotional Assessment (BITSEA) score
timeFrame: 15 months
Secondary outcomes:
measure: Change in Parenting Stress Index (PSI-4)
timeFrame: 6 months (over the phone) and 15 months (in person)
measure: Change in Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 15 months
measure: Change in Bayley-III Scale
timeFrame: 15 months
measure: Change in Toddler Sensory Profile-2 score
timeFrame: 15 months
measure: Change in M/CHAT R/F score
timeFrame: 15 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital of New York
state: New York
Study officials:
affiliation: Columbia University
name: Dani Dumitriu, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beebe B, Myers MM, Lee SH, Lange A, Ewing J, Rubinchik N, Andrews H, Austin J, Hane A, Margolis AE, Hofer M, Ludwig RJ, Welch MG. Family nurture intervention for preterm infants facilitates positive mother-infant face-to-face engagement at 4 months. Dev Psychol. 2018 Nov;54(11):2016-2031. doi: 10.1037/dev0000557. Epub 2018 Oct 4.
citation: Isler JR, Stark RI, Grieve PG, Welch MG, Myers MM. Integrated information in the EEG of preterm infants increases with family nurture intervention, age, and conscious state. PLoS One. 2018 Oct 24;13(10):e0206237. doi: 10.1371/journal.pone.0206237. eCollection 2018.
citation: Welch MG, Hofer MA, Brunelli SA, Stark RI, Andrews HF, Austin J, Myers MM; Family Nurture Intervention (FNI) Trial Group. Family nurture intervention (FNI): methods and treatment protocol of a randomized controlled trial in the NICU. BMC Pediatr. 2012 Feb 7;12:14. doi: 10.1186/1471-2431-12-14.
citation: Welch MG, Hofer MA, Stark RI, Andrews HF, Austin J, Glickstein SB, Ludwig RJ, Myers MM; FNI Trial Group. Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety. BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
citation: Welch MG, Firestein MR, Austin J, Hane AA, Stark RI, Hofer MA, Garland M, Glickstein SB, Brunelli SA, Ludwig RJ, Myers MM. Family Nurture Intervention in the Neonatal Intensive Care Unit improves social-relatedness, attention, and neurodevelopment of preterm infants at 18 months in a randomized controlled trial. J Child Psychol Psychiatry. 2015 Nov;56(11):1202-11. doi: 10.1111/jcpp.12405. Epub 2015 Mar 11.
citation: Feldman R, Magori-Cohen R, Galili G, Singer M, Louzoun Y. Mother and infant coordinate heart rhythms through episodes of interaction synchrony. Infant Behav Dev. 2011 Dec;34(4):569-77. doi: 10.1016/j.infbeh.2011.06.008. Epub 2011 Jul 20.