Family Nurture Intervention in the NICU

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

COMPLETED

Clinical Phase

NA

Total Enrollment

461 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-24

Study Completion Date

2022-12-31

Brief Summary

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The purpose of this study is to compare neurodevelopment and activity in infants born very preterm (26 to 33 6/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The study investigator hypothesizes that FNI will improve: i) neonatal electroencephalographic activity ii) maternal caregiving and wellbeing (psychological and physiological), and iii) infant behavior and neurodevelopment at 18 months corrected age (CA).

The study aims to:

\- Replicate efficacy from an earlier trial by conducting the study at multiple sites to allow for greater generalizability.

* SC, approximately 90 infants plus the parents
* FNI, approximately 90 infants plus the parents
* Term Controls, approximately 25 infants plus the parents

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Detailed Description

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Increasing number of studies demonstrating the importance of early mother-infant nurturing interaction on long-term outcomes demonstrates the need for a prevention/remedial intervention in the neonatal intensive care unit (NICU). The foremost goal of neonatal intensive care is to ensure survival and medical stability of the infant. Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival. Thus, a necessary but detrimental separation between mother and infant is created at a critical period when mother-infant connection and synchrony should be developing. The physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions, are key factors underlying the risks of premature infants for a broad range of early and midlife disorders.

Not only are preterm infants at increased risk for adverse outcomes (\>50%), but up to 40% of mothers of these infants suffer from depression during the postpartum period and many mothers suffer symptoms of trauma and post-traumatic stress. Importantly, fathers of preterm infants are also at increased for postnatal depression. In addition, a recent review of 10 studies found that mothers of preterm infants are at increased risk for subsequent ischemic heart disease, stroke, atherosclerosis, and death due to cardiovascular disease (CVD). Delivery of a preterm infant has long lasting effects on both parents with both mothers and fathers reporting increased parenting stress when their infants reached 7 years of age.

This study will allow examination of the immediate and long-term effects of new approach on the development of preterm infants and cardiovascular risk of their parents.

Conditions

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Premature Birth Obstetric Labor, Premature

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care

Preterm infants will receive current Standard Care (SC) in the NICU.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Established routine care provided on the NICU floor by specially trained health care professionals.

Intervention

Preterm infants will receive Family Nurture Intervention (FNI) in addition to current Standard Care (SC) in the NICU. Specifically, staff will support the parents and facilitate contact between mother and infant during the NICU stay.

Group Type EXPERIMENTAL

Family Nurture Intervention

Intervention Type BEHAVIORAL

Family Nurture Intervention is facilitated by specially trained Nurture Specialists in a randomized controlled trial (RCT) model (Part I) or applied unit-wide (either through dedicated staff or bedside nurses in Part II). Under FNI, specialists or nurses will support the parents and facilitate contact between mother and baby during the infant's NICU stay. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.

Standard Care

Intervention Type BEHAVIORAL

Established routine care provided on the NICU floor by specially trained health care professionals.

Term Controls

Full term infants will receive current Standard Care (SC) in the NICU. Term Controls (TC)

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Established routine care provided on the NICU floor by specially trained health care professionals.

Chart Review

Chart review will be conducted to acquire a comparison group to determine if our study participants differ from the non-study population.

Group Type ACTIVE_COMPARATOR

Standard Care

Intervention Type BEHAVIORAL

Established routine care provided on the NICU floor by specially trained health care professionals.

Interventions

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Family Nurture Intervention

Family Nurture Intervention is facilitated by specially trained Nurture Specialists in a randomized controlled trial (RCT) model (Part I) or applied unit-wide (either through dedicated staff or bedside nurses in Part II). Under FNI, specialists or nurses will support the parents and facilitate contact between mother and baby during the infant's NICU stay. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.

Intervention Type BEHAVIORAL

Standard Care

Established routine care provided on the NICU floor by specially trained health care professionals.

Intervention Type BEHAVIORAL

Other Intervention Names

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FNI SC

Eligibility Criteria

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Inclusion Criteria

* Infant is between 26 and 33 6/7 weeks gestational age upon admission
* Infant is a singleton or twin

* Infant is born between 38-42 weeks gestation
* Infant is singleton or twin

Exclusion Criteria

* Infant's attending physician does not recommend enrollment in the study
* Severe congenital anomalies including chromosomal anomalies
* Ultrasound evidence of large parenchymal hemorrhagic infarction (\>2 cm, intraventricular hemorrhage grade 3 or 4)
* Infant cardiac anomalies
* Mother has known history of substance abuse, severe psychiatric illness or psychosis
* Mother and/or infant has a medical condition that precludes intervention components
* Mother and/or infant has a contagion that endangers other participants in the study

For the TC Group (enrolled at one site: MSCHONY)

* Infant's attending physician does not recommend enrollment in the study
* Severe congenital anomalies including chromosomal anomalies
* Ultrasound evidence of large parenchymal hemorrhagic infarction (\>2 cm, intraventricular hemorrhage grade 3 or 4)
* Infant cardiac anomalies
* Mother has known history of substance abuse, severe psychiatric illness or psychosis
* Mother and/or infant has a medical condition that precludes intervention components
* Mother and/or infant has a contagion that endangers other participants in the study

Minimum Eligible Age

26 Weeks

Maximum Eligible Age

34 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No