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Completed

NCT Number: NCT02710474

Family Nurture Intervention in the NICU

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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Key information

Age range

26 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Morgan Stanley Children's Hospital of New York (MSCHONY), New York, United States

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About this study

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 Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For the FNI and SC Groups (enrolled competitively at across all participating sites)

Inclusion criteria

  • Infant is between 26 and 33 6/7 weeks gestational age upon admission
  • Infant is a 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
  • Status of enrolled subject changes and subject now falls into exclusion 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

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

Inclusion criteria

  • 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
  • Status of enrolled subject changes and subject now falls into exclusion 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

Treatment and study plan

Family Nurture Intervention

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.

Other names: FNI

Standard Care

Behavioral

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

Other names: SC

Primary outcomes

  1. EEG Power in the frontal polar region

    Time frame: Infant Age at 39-41 Weeks gestational age

    Measured in microvolts (µV)^2

Secondary outcomes

  1. EEG Coherence in the left frontal polar to right frontal polar region

    Time frame: Infant Age at 39-41 Weeks gestational age

    Coherence is a number between 0-1, generated by looking at the similarity/differences in activity between brain regions through analysis of electroencephalogram (EEG).

  2. CES-D Score

    Time frame: Up to 18 months

    To examine maternal depression. The Center for Epidemiologic Studies Depression Scale (CES-D) is a 20 item self-report inventory designed to assess current but nonspecific distress rather than clinically diagnosed depression. It is the most frequently used measure in the field of infant research and maternal depression. Items probe for depressive symptoms and attitudes within the past week. The investigators will examine a low-scoring group CES-D = 0, 1, who endorse no distress.

  3. STAI Score

    Time frame: Up to 18 months

    To examine Maternal Anxiety. The State-Trait Anxiety Inventory (STAI) comprises 2 separate self-report scales of 20 items each that measure state and trait anxiety (Spanish version also available). The S-Anxiety Scale (measuring state), has been found to be a sensitive indicator of changes in transitory anxiety experienced by patients in counseling, psychotherapy, and behavior-modification programs, and has been used to assess the level of anxiety induced by unavoidable real-life stressors. The T-Anxiety scale has proven useful for identifying persons who differ in motivation or drive level. The STAI has been used in studies examining parents of hospitalized children, the transition to a maternal role, perception of illness severity in infants, and maternal anxiety during pregnancy and fetal attachment.

  4. Neurobehavioral Assessment of Infants - Bayley Scales of Infant and Toddler Development, Bayley III

    Time frame: 18 Month corrected age Follow-Up

    At the 18 month corrected age follow-up, infants are administered the Bayley Scales of Infant and Toddler Development, Bayley III consisting of three developmental domains: Cognitive, Language (receptive/expressive) and Motor (fine/gross). For each domain, a composite score is provided and is scaled to a mean score of 100 and a standard deviation of 15. A child will receive 1 point for every item successfully completed. The administration of each section will end if the child received 0 points on 5 consecutive items. Scores <70 indicate significant developmental delays and scores <80 indicate mild to moderate developmental delays.

    Cognitive Scale - comprised of 91 items Language Scale - comprised of 97 items Motor Scale - comprised of 138 items

Other outcomes

  1. Welch Emotional Connection Scale

    Time frame: Up to 18 months

    To examine Mother-Infant Emotional Connection. This is a brief, 4-item assessment requiring 5 minutes or less, which assesses the character of the relationship between study mothers and infants. It is filled out by study staff, who rate mothers and infants in a dyadic interaction on their attraction, their motivation to verbally communicate, their sensitivity to each other, their responsivity to each other, and their communication with physical/facial gestures on independent 3-point scales.

  2. Child Behavior Checklist Score

    Time frame: 18 Month corrected age Follow-Up

    The Child Behavior Checklist (CBCL) is a device by which parents rate a child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items.

  3. Modified Checklist for Autism in Toddlers (M-CHAT) Score

    Time frame: 18 Month corrected age Follow-Up

    The M-CHAT is a questionnaire validated for screening toddlers to assess risk for autism spectrum disorders (ASD). It is a 23 yes/no item questionnaire administered to the mother which can be scored in less than two minutes. The investigators will administer the M-CHAT during the 18 month follow up visit.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Einhorn Family Charitable Trust

Registry information

Official study title

Family Nurture Intervention in the NICU: A Multi-Site Trial

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Mar 16, 2016
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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