Family Nurture Intervention in the CHoNJ NICU
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2015 |
| End Date: | June 2017 |
Randomized Control Trial of Family Nurture Intervention in the Children's Hospital of New Jersey Neonatal Intensive Care Unit
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.
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.
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.
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.
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)
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