Family Nurture Intervention in the NICU at The Valley Hospital

February 13, 2023 updated by: Martha G Welch, Columbia University

The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU).

The investigators hypothesize 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 two-phase effectiveness study aims to:

  • Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers
  • Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

Study Overview

Detailed Description

This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.

The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.

Study Type

Interventional

Enrollment (Actual)

150

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

    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • New York, New York, United States, 10032
        • Morgan Stanley Children's Hospital of New York (MSCHONY)

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 Standard Care and FNI Groups

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

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: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Care
Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital.
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC
Experimental: Family Nurture Intervention (FNI)
Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay.
Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
Other Names:
  • FNI
Active Comparator: Standard Care - Case Studies
Participants enrolled as case studies in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital. These participants will be those who fall outside the inclusion criteria.
Established routine care provided on the NICU floor by specially trained health care professionals.
Other Names:
  • SC
Experimental: FNI - Case Studies
Participants enrolled in Phase 2 will be receiving family nurture intervention (FNI) that focuses on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. These fall outside the inclusion criteria but act as a comparator to the case studies of Phase 1.
Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
Other Names:
  • FNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG Power in the frontal polar region
Time Frame: Up to 41 weeks gestational age
Measured in microvolts (µV)^2 for infants.
Up to 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: Up to 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 EEG.
Up to 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.
Up to 18 months
State-Trait Anxiety Inventory (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. 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 Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III
Time Frame: Up to 18 months

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

Up to 18 months

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 vocal communication, facial expressiveness, and sensitivity and responsivity towards each other.
Up to 18 months
Child Behavior Checklist Score
Time Frame: Up to 18 months
The Child Behavior Checklist (CBCL) is a device by which parents rate their 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. This will be administered at the 18 Months CA Follow-Up.
Up to 18 months
Modified Checklist for Autism in Toddlers (M-CHAT) Score
Time Frame: Up to 18 months
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 2 minutes. This will be administered at the 18 Month CA Follow-Up.
Up to 18 months

Collaborators and Investigators

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

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)

October 20, 2017

Primary Completion (Actual)

March 19, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

August 28, 2017

First Posted (Actual)

August 30, 2017

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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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