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Family Nurture Intervention in the CHoNJ NICU

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ClinicalTrials.gov Identifier: NCT02352142
Recruitment Status : Terminated (insufficient enrollment numbers)
First Posted : February 2, 2015
Last Update Posted : September 26, 2016
Sponsor:
Collaborator:
Newark Beth Israel Medical Center
Information provided by (Responsible Party):
Martha G. Welch, MD, Columbia University

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.


Condition or disease Intervention/treatment Phase
Premature Birth Other: Full Term EEG Behavioral: Facilitated Infant Care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Family Nurture Intervention in the Children's Hospital of New Jersey Neonatal Intensive Care Unit
Study Start Date : January 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
No Intervention: Standard Care
Mothers are given infant care instruction as part of standard care
Experimental: Facilitated infant care
Family Nurture Intervention
Behavioral: Facilitated Infant Care
Family Nurture Intervention is facilitated by specially trained Nurture Specialists. 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.
Other Name: Family Nurture Intervention

Full Term EEG
Small group of healthy, Full-Term infants will receive two sleep EEGs (one in unit, and one 4 weeks post discharge) for healthy control comparison to preterm infants
Other: Full Term EEG
Full-term infants assigned to this arm of the study will receive one sleep EEG (one hour in duration). These EEGs will be used as healthy control comparisons to those of premature infants at 40 weeks.




Primary Outcome Measures :
  1. EEG measures of power and coherence [ Time Frame: 34 weeks gestational age through term age ]
    Two one-hour sleep EEGs will take place. One at 34-36 weeks Gestational Age, and one at term age


Secondary Outcome Measures :
  1. Maternal measures of anxiety, depression and care-giving [ Time Frame: Up to 12 months of age ]
    Measures of maternal depression and anxiety and maternal care-giving will be compared between standard care and intervention groups using analyses of variance. The measures will also be compared within groups, using repeated measures ANOVA.

  2. Measure of mother time spent with infant in unit and in skin to skin [ Time Frame: Duration of infant stay in unit (roughly 35 days) ]
    Measures of parental visiting hours and occurrence of skin to skin will be compared within groups. We will use parent and nurture specialist report to measure parental visiting hours and occurrence of skin to skin.

  3. Neurobehavioral Assessments of Infants- Bayley Scales of Infant and Toddler Development, Bayley III [ Time Frame: Up to 12 month corrected age ]
    At 4 and 12 months corrected age, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of four subscales: Cognitive, Language (receptive/expressive), Motor (fine/gross) and Social-Emotional. These filmed assessments, made by research staff 'blind' to infant group assignment, provide information about the neurobehavioral status of the child and whether there are significant delays in key domains of motor, language, and cognitive development.

  4. Physiological Assessments- salivary cortisol [ Time Frame: Up to 24 months corrected age ]
    As a component of the mother-infant interaction assessments conducted at 4 and 12 months corrected age, salivary cortisol levels are measured at four times during each session. These measures provide physiological indices of how the infants respond to a social interaction stressor.

  5. Physiological Assessments- breast milk [ Time Frame: The duration of the infant stay in unit, or an average of 5 weeks ]
    Breast milk collections will be analyzed in order to measure levels of pro-inflammatory cytokines, oxytocin and other peptides.

  6. Physiological Assessments- infant stool collection [ Time Frame: The duration of the infant stay in unit, or an average of 5 weeks ]
    Infant stool collections will be made in order to measure levels of inflammation-related cytokines and other peptides.

  7. Physiological Assessments- infant blood samples [ Time Frame: The duration of the infant stay in unit, or an average of 5 weeks ]
    Infant blood samples will be collected by piggy-backing off of standard care heel-sticks by hospital staff. These samples will be analyzed for presence of oxytocin and other applicable peptides

  8. Mother-Infant Interactions Assessments: Evaluating the qualities of the mother's interaction with her infant during diaper change [ Time Frame: Up to 4 months corrected age ]
    Videos of infant's diaper change are obtained and coded by research team members unfamiliar with the dyads' group assignment at 4 months corrected age. The mother is instructed to undress her infant, remove the diaper, wipe clean, and re-dress her infant. These familiar caregiving procedures represent a mild, ecologically valid stressor. Maternal behavior is coded, using a 9-point Likert scale for: (a) Acceptance vs. Rejection; (b) Soothing capability; (c) Consideration vs. Intrusiveness; (d) Quality of Physical Contact; and (e) Quality of Vocal Contact.

  9. 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 [ Time Frame: Up to 12 months corrected age ]
    A split-screen filming session is conducted following protocols and analyzed by team members 'blind' to the dyads' group assignments at 4, 12, and 24 months corrected age. The videotapes consist of: (1) mother-infant play; (2) stranger-infant play (3) diaper change; (4) the Still Face protocol in which mothers assume an expressionless face for two minutes. Primary measures are: infant gaze aversion, mother-infant gaze coordination, infant distress, maternal interaction style (affectionate vs. intrusive), and responses of mothers and infants to gaze aversion. Additionally, research staff blind to group assignment will assess the quality of the mother-infant interaction with the Biphasic Emotional Connection Scale.



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Ages Eligible for Study:   26 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352142


Locations
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United States, New Jersey
Children's Hospital of New Jersey
Newark, New Jersey, United States, 07112
United States, New York
Columbia University Data Coordinating Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Newark Beth Israel Medical Center
Investigators
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Principal Investigator: Martha G Welch, MD Columbia University Medical Center, Presbyterian Hospital
Publications:

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Responsible Party: Martha G. Welch, MD, Assistant Professor, Columbia University
ClinicalTrials.gov Identifier: NCT02352142    
Other Study ID Numbers: AAAN6850
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: September 26, 2016
Last Verified: July 2016
Keywords provided by Martha G. Welch, MD, Columbia University:
Separation stress
Family Nurture
Maternal Confidence
Maternal Competence
Calming Cycle
Kangaroo Care
Infant Neurodevelopment
Infant Psychological Development
Post-partum depression
Mother-infant Co-regulation
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications