Family Nurture Intervention in the NICU at The Valley Hospital

NCT03267043 | Completed DMC

• 1 other identifier: AAAR4899
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Premature Birth; Obstetric Labor, Premature

Keywords

preterm birth; NICU; neonatal; skin to skin; kangaroo care; separation stress; family nurture; maternal confidence; maternal competence; calming cycle; infant neurodevelopment; infant psychological development; mother-infant co-regulation; postpartum depression

Outcome Measures

Primary Outcomes (1)

• EEG Power in the frontal polar region

  Measured in microvolts (µV)\^2 for infants.

  Up to 41 weeks gestational age

Secondary Outcomes (4)

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

  Up to 41 weeks gestational age

• CES-D Score

  Up to 18 months

• State-Trait Anxiety Inventory (STAI) Score

  Up to 18 months

• Neurobehavioral Assessments of Infants - Bayley Scales or Infant and Toddler Development, Bayley III

  Up to 18 months

Other Outcomes (3)

• Welch Emotional Connection Scale

  Up to 18 months

• Child Behavior Checklist Score

  Up to 18 months

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

  Up to 18 months

Study Arms (4)

Standard Care

ACTIVE COMPARATOR

Participants enrolled in Phase 1 will be receiving the current standard of care in the NICU at The Valley Hospital.

Behavioral: Standard Care

Family Nurture Intervention (FNI)

EXPERIMENTAL

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.

Behavioral: Family Nurture Intervention (FNI)

Standard Care - Case Studies

ACTIVE COMPARATOR

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.

Behavioral: Standard Care

FNI - Case Studies

EXPERIMENTAL

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.

Behavioral: Family Nurture Intervention (FNI)

Interventions

Family Nurture Intervention (FNI) BEHAVIORAL

Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.

Also known as: FNI

FNI - Case Studies; Family Nurture Intervention (FNI)

Standard Care BEHAVIORAL

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

Also known as: SC

Standard Care; Standard Care - Case Studies

Eligibility Criteria

• Age: 26 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• infant is between 26 and 33 6/7 weeks gestational age upon admission
• infant is a singleton or twin

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (2)

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

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

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Premature Birth; Obstetric Labor, Premature; Depression, Postpartum

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Martha G Welch, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: October 20, 2017
• Primary Completion: March 19, 2020
• Study Completion: July 1, 2020
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (2)