Clinical trial NCT02352142: Family Nurture Intervention in the CHoNJ NICU
Official title: Randomized Control Trial of Family Nurture Intervention in the Children's Hospital of New Jersey Neonatal Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Premature Birth
Keywords: Separation stress
Family Nurture
Maternal Confidence
Maternal Competence
Calming Cycle
Kangaroo Care
Infant Neurodevelopment
Infant Psychological Development
Post-partum depression
Mother-infant Co-regulation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Newark Beth Israel Medical Center
First posted: 2015-02-02
Enrollment: 54
Sex: ALL
Minimum age (years): 26
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this proposal is to conduct a replication study of Family Nurture Intervention (FNI) at CHoNJ. FNI facilitates mother-infant interactions that are vital to early development. These include early and repeated mother/infant calming interactions during the NICU stay, such as interactive touch with vocal soothing, sustained reciprocal olfactory exposure and family practice in comforting, and systematically implemented skin to skin holding. This has already been studied at CHONY. Findings reveal that infants who receive FNI have significant increases in EEG power, a measure of brain activity, near to term age, when compared with those who receive Standard Care.

There will be two groups; STANDARD CARE (SC) and INTERVENTION (FNI). In addition, 10 pilot subjects will be enrolled to train the staff involved in the procedures used in this Randomized Control Trial (RCT). The pilot patients will be enrolled identical to study patients and will be encouraged to participate fully. They will not be included in the analysis of the RCT.

The STANDARD CARE group will receive current standard of care in NICU. The INTERVENTION group, in addition to the standard care, will receive the FNI intervention, which will be facilitated by our Nurture Specialists. In addition to the SC and FNI groups, there will be a third non-randomized group of infants born at term age who will receive standard care for newborns at CHoNJ. Assessments in the NICU will include physiological measures (ECG EEG), measures of maternal sensitivity through recorded mother-infant interactions and a variety of specimen collections (saliva, blood, and breast milk samples). The investigators will be conducting two follow up studies, at 4 months corrected age and at 12 months corrected age. The investigators will test the immediate and long-term effects of this approach to the development of preterm infants.

The investigators hypothesize that this intervention will alter a wide range of indices of physiological regulatory capacities, and increase brain activity as measured by EEG (power and coherence) such that a brain activation pattern in the intervention group will be more similar to that of full term infants as opposed to the standard care group. Longer term indices of mother psychological and infant neurobehavioral outcomes will also be improved when assessed during the first few months of life.

Detailed description: The purpose of this study is to compare the value of the current approach of encouraging contact between mothers and their babies (Standard Care) in the NICU with a more wide ranging enhanced approach (Family Nurture Intervention). This approach is based on enhancing aspects of maternal nurturing including mother-infant reciprocal calming, which are vital to early development. A specific goal is to improve the mother's view of her baby, reduce negative emotions about having delivered a baby prematurely, and help her gain confidence in her caretaking abilities. Since preterm babies are often easily upset, this study will facilitate mothers in comforting and calming their babies. An earlier study at Morgan Stanley Children's Hospital of New York (CHONY) has shown positive outcomes in the enhanced treatment group in a variety of areas, including EEG brain activity at term age. Assessments in the NICU and in secondary follow-up measures at 4, and 12 months of age will test the immediate and long-term effects of this new enhanced approach to the nurture of prematurely born infants. We will undertake a replication study on patients in the NICU at CHoNJ to confirm and further elucidate the positive effects of enhanced nurturing.

We hypothesize that enhanced nurturing will alter a wide range of physiologic regulatory capacities, reduce morbidity, decrease Length of Stay (LOS) and increase brain activity as measured by EEG (power and coherence). In addition this approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant. Longer term measures of mother's psychological and infant's neurobehavioral outcomes will also be improved when assessed during the first few months of life.

This study aims to replicate and build on an existing study at Morgan Stanley Children's Hospital of New York (CHONY) that compares the current protocol for encouraging mother/infant interactions (standard care) with a multifaceted intervention to enhance mother and infant bonding (Family Nurture Intervention - FNI). The FNI was piloted and studied in a cohort of 150 mother-infant pairs at CHONY beginning in 2009. While the study is ongoing, significant differences in brain activity of these preterm infants was found at term as measured by EEG power in the intervention premature infants as compared to the standard care group, with no increased risk of morbidity or mortality in the intervention group. The study demonstrated that the approach may influence a brain activation pattern (particularly in the area of the anterior cerebral cortex responsible for executive decision-making) in the intervention group that is more similar to that of a full term infant (38-42 weeks gestation).

This and other research warrants the investigation of better intervention strategies that can reduce morbidity and ameliorate adverse outcomes in these infants.

The purpose of this current study is to determine whether the findings from CHONY are replicable, the efficacy of the FNI protocol in improving developmental outcomes in preterm births in a different cohort (at CHoNJ) and to compare the outcomes of patients in two different hospital environments.

The study will again compare the current standard of care in the NICU, which includes periodic skin-to-skin holding, to a Family Nurture Intervention (FNI) which adds other interventions: interactive touch with vocal soothing, sustained reciprocal olfactory exposure, and family modeling and practice in comforting as well as a more systematic implementation of skin-to-skin holding. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better prevention of developmental disorders, reduced morbidity and more effective clinical intervention strategies both in the neonatal intensive care unit (NICU) and after discharge. We hypothesize that the treated babies will show better results in the primary outcome measure in the short term and secondary long term as compared to infants undergoing standard care.

Eligibility criteria: Inclusion Criteria:

* Infant is between 26/0 and 32/6 weeks gestational age upon admission for the INTERVENTION / STANDARD care group OR 38-42 weeks for the FULL TERM group
* Infant's weight is appropriate for gestational age (AGA)
* Infant is a singleton
* Mother is 18 years of age or older
* Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent) (not applicable for FULL TERM group)

Exclusion Criteria:

* Infant's attending does not recommend enrollment in study
* The infant has severe congenital anomalies, including chromosomal anomalies or an Intraventricular Hemorrhage (IVH) Grades 3 and 4
* Mother has known history of substance abuse, severe psychiatric illness or psychosis
* Status of enrolled subject changes and subject no longer falls in inclusion criteria
* 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
* Mother-Infant dyad receives less than one week of intervention (not applicable to the FULL TERM group)

Primary outcomes:
measure: EEG measures of power and coherence
timeFrame: 34 weeks gestational age through term age
Secondary outcomes:
measure: Maternal measures of anxiety, depression and care-giving
timeFrame: Up to 12 months of age
measure: Measure of mother time spent with infant in unit and in skin to skin
timeFrame: Duration of infant stay in unit (roughly 35 days)
measure: Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III
timeFrame: Up to 12 month corrected age
measure: Physiological Assessments- salivary cortisol
timeFrame: Up to 24 months corrected age
measure: Physiological Assessments- breast milk
timeFrame: The duration of the infant stay in unit, or an average of 5 weeks
measure: Physiological Assessments- infant stool collection
timeFrame: The duration of the infant stay in unit, or an average of 5 weeks
measure: Physiological Assessments- infant blood samples
timeFrame: The duration of the infant stay in unit, or an average of 5 weeks
measure: Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change
timeFrame: Up to 4 months corrected age
measure: Mother-Infant Interaction Assessments: Mother-infant face-to-face communicative competence, sensitivity of maternal caregiving and mother and infant physiological capacity to cope with a stressor
timeFrame: Up to 12 months corrected age
Other outcomes:
Locations:
city: Newark
country: United States
facility: Children's Hospital of New Jersey
state: New Jersey
city: New York
country: United States
facility: Columbia University Data Coordinating Center
state: New York
Study officials:
affiliation: Columbia University Medical Center, Presbyterian Hospital
name: Martha G Welch, MD
role: PRINCIPAL_INVESTIGATOR
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