Family Nurture Intervention in the NICU at The Valley Hospital

NCT ID: NCT03267043

Last Updated: 2023-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-20
• Study Completion Date: 2020-07-01

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

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.

Conditions

Premature Birth; Obstetric Labor, Premature

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Standard Care

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

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Family Nurture Intervention (FNI)

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Standard Care

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Family Nurture Intervention (FNI)

Intervention Type: BEHAVIORAL

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

Interventions

Family Nurture Intervention (FNI)

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

Intervention Type: BEHAVIORAL

Standard Care

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

Intervention Type: BEHAVIORAL

Other Intervention Names

FNI; SC

Eligibility Criteria

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
• 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

• Minimum Eligible Age: 26 Weeks
• Maximum Eligible Age: 34 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Martha G Welch

Associate Professor of Psychiatry (in Pediatrics and Pathology and Cell Biology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martha G Welch, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

The Valley Hospital

Ridgewood, New Jersey, United States

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

New York, New York, United States

Countries

United States

Other Identifiers

AAAR4899

Identifier Type: -

Identifier Source: org_study_id