Family Nurture Intervention in the NICU

February 14, 2023 updated by: Columbia University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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 Within the NICU, parental involvement in care is necessarily superseded by the healthcare staff's need to assure survival.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

Study Type

Interventional

Enrollment (Actual)

461

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital of New York (MSCHONY)
    • Texas
      • San Antonio, Texas, United States, 78229
        • University Texas Health Science Center San Antonio (UTHSCSA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care
Preterm infants will receive current Standard Care (SC) in the NICU.
Behavioral: Standard Care
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC
Experimental: 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.
Behavioral: Standard Care
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC
Behavioral: 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.
Other Names:
  • FNI
Active Comparator: Term Controls
Full term infants will receive current Standard Care (SC) in the NICU. Term Controls (TC)
Behavioral: Standard Care
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC
Active Comparator: Chart Review
Chart review will be conducted to acquire a comparison group to determine if our study participants differ from the non-study population.
Behavioral: Standard Care
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG Power in the frontal polar region
Time Frame: Infant Age at 39-41 Weeks gestational age
Measured in microvolts (µV)^2
Infant Age at 39-41 Weeks gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Infant Age at 39-41 Weeks gestational age
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.
Up to 18 months
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.
Up to 18 months
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
18 Month corrected age Follow-Up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 18 months
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.
18 Month corrected age Follow-Up
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.
18 Month corrected age Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Einhorn Family Charitable Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Actual)

February 7, 2020

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAQ7504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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