Clinical Interventions to Mitigate Neurodevelopmental Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-03

Study Completion Date

2020-03-13

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Child Development Mother-Infant Interaction Diabetes Mellitus, Gestational

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Family Nurture Intervention (FNI)

This arm contains the combined GDM+FNI and control+FNI cohort.

Group Type EXPERIMENTAL

Family Nurture Intervention (FNI)

Intervention Type BEHAVIORAL

FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician.

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).

Non-FNI

This arm contains the combined GDM+no FNI and control+no FNI cohort.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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 physician.

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

12 Hours

Maximum Eligible Age

3 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes