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Family Nurture Intervention in the NICU

Primary Purpose

Premature Birth, Obstetric Labor, Premature

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Family Nurture Intervention

Standard Care

About this trial

This is an interventional other trial for Premature Birth focused on measuring preterm birth, NICU, neonatal, kangaroo care, separation stress, family nurture, maternal confidence, maternal competence, calming cycle, infant neurodevelopment, infant psychological development, mother-infant co-regulation, post-partum depression

Eligibility Criteria

26 Weeks - 34 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Morgan Stanley Children's Hospital of New York (MSCHONY)
University Texas Health Science Center San Antonio (UTHSCSA)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

Standard Care

Intervention

Term Controls

Chart Review

Arm Description

Preterm infants will receive current Standard Care (SC) in the NICU.

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.

Full term infants will receive current Standard Care (SC) in the NICU. Term Controls (TC)

Chart review will be conducted to acquire a comparison group to determine if our study participants differ from the non-study population.

Outcomes

Primary Outcome Measures

EEG Power in the frontal polar region

Measured in microvolts (µV)^2

Secondary Outcome Measures

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

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

CES-D Score

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.

STAI Score

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.

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

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

Full Information

NCT ID

NCT02710474

First Posted

March 7, 2016

Last Updated

February 14, 2023

Sponsor

Columbia University

Collaborators

Einhorn Family Charitable Trust

1. Study Identification

Unique Protocol Identification Number

NCT02710474

Brief Title

Family Nurture Intervention in the NICU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Completed

Study Start Date

January 24, 2017 (Actual)

Primary Completion Date

February 7, 2020 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

Collaborators

Einhorn Family Charitable Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth, Obstetric Labor, Premature

Keywords

preterm birth, NICU, neonatal, kangaroo care, separation stress, family nurture, maternal confidence, maternal competence, calming cycle, infant neurodevelopment, infant psychological development, mother-infant co-regulation, post-partum depression

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

461 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Care

Arm Type

Active Comparator

Arm Description

Preterm infants will receive current Standard Care (SC) in the NICU.

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Term Controls

Arm Type

Active Comparator

Arm Description

Full term infants will receive current Standard Care (SC) in the NICU. Term Controls (TC)

Arm Title

Chart Review

Arm Type

Active Comparator

Arm Description

Chart review will be conducted to acquire a comparison group to determine if our study participants differ from the non-study population.

Intervention Type

Behavioral

Intervention Name(s)

Family Nurture Intervention

Other Intervention Name(s)

FNI

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

Standard Care

Other Intervention Name(s)

Intervention Description

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

Primary Outcome Measure Information:

Title

EEG Power in the frontal polar region

Description

Measured in microvolts (µV)^2

Time Frame

Infant Age at 39-41 Weeks gestational age

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

Infant Age at 39-41 Weeks gestational age

Title

CES-D Score

Description

Time Frame

Up to 18 months

Title

STAI Score

Description

Time Frame

Up to 18 months

Title

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

Description

Time Frame

18 Month corrected age Follow-Up

Other Pre-specified Outcome Measures:

Title

Welch Emotional Connection Scale

Description

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.

Time Frame

Up to 18 months

Title

Child Behavior Checklist Score

Description

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.

Time Frame

18 Month corrected age Follow-Up

Title

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

Description

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.

Time Frame

18 Month corrected age Follow-Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

26 Weeks

Maximum Age & Unit of Time

34 Weeks

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martha G Welch, MD

Organizational Affiliation

CUMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

University Texas Health Science Center San Antonio (UTHSCSA)

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25911131

Citation

Helle N, Barkmann C, Bartz-Seel J, Diehl T, Ehrhardt S, Hendel A, Nestoriuc Y, Schulte-Markwort M, von der Wense A, Bindt C. Very low birth-weight as a risk factor for postpartum depression four to six weeks postbirth in mothers and fathers: Cross-sectional results from a controlled multicentre cohort study. J Affect Disord. 2015 Jul 15;180:154-61. doi: 10.1016/j.jad.2015.04.001. Epub 2015 Apr 10.

Results Reference

background

PubMed Identifier

24055578

Citation

Robbins CL, Hutchings Y, Dietz PM, Kuklina EV, Callaghan WM. History of preterm birth and subsequent cardiovascular disease: a systematic review. Am J Obstet Gynecol. 2014 Apr;210(4):285-297. doi: 10.1016/j.ajog.2013.09.020. Epub 2013 Sep 18.

Results Reference

background

PubMed Identifier

12685667

Citation

Holditch-Davis D, Bartlett TR, Blickman AL, Miles MS. Posttraumatic stress symptoms in mothers of premature infants. J Obstet Gynecol Neonatal Nurs. 2003 Mar-Apr;32(2):161-71. doi: 10.1177/0884217503252035.

Results Reference

background

PubMed Identifier

35358769

Citation

Welch MG, Grieve PG, Stark RI, Isler JR, Ludwig RJ, Hane AA, Gong A, Darilek U, Austin J, Myers MM. Family nurture intervention increases term age forebrain EEG activity: A multicenter replication trial. Clin Neurophysiol. 2022 Jun;138:52-60. doi: 10.1016/j.clinph.2022.02.018. Epub 2022 Mar 5.

Results Reference

derived

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Family Nurture Intervention in the NICU

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