Family Nurture Intervention in the NICU

NCT02710474 | Completed DMC

• 1 other identifier: AAAQ7504
• Study Type: interventional
• Target: 461
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• EEG Power in the frontal polar region

  Measured in microvolts (µV)\^2

  Infant Age at 39-41 Weeks gestational age

Secondary Outcomes (4)

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

  Infant Age at 39-41 Weeks gestational age

• CES-D Score

  Up to 18 months

• STAI Score

  Up to 18 months

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

  18 Month corrected age Follow-Up

Other Outcomes (3)

• Welch Emotional Connection Scale

  Up to 18 months

• Child Behavior Checklist Score

  18 Month corrected age Follow-Up

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

  18 Month corrected age Follow-Up

Study Arms (4)

Standard Care

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Intervention

EXPERIMENTAL

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: Family Nurture Intervention; Behavioral: Standard Care

Term Controls

ACTIVE COMPARATOR

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

Behavioral: Standard Care

Chart Review

ACTIVE COMPARATOR

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

Interventions

Family Nurture Intervention BEHAVIORAL

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.

Also known as: FNI

Intervention

Standard Care BEHAVIORAL

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

Also known as: SC

Chart Review; Intervention; Standard Care; Term Controls

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
• For the TC Group (enrolled at one site: MSCHONY)
• Infant is born between 38-42 weeks gestation
• Infant is singleton or twin
• 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

Sponsors & Collaborators

• Columbia University: lead
• Einhorn Family Charitable Trust: collaborator

Study Sites (2)

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

New York, New York, 10032, United States

Location

University Texas Health Science Center San Antonio (UTHSCSA)

San Antonio, Texas, 78229, United States

Location

Related Publications (4)

• 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.

  PMID: 25911131 BACKGROUND

• 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.

  PMID: 24055578 BACKGROUND

• 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.

  PMID: 12685667 BACKGROUND

• 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.

  PMID: 35358769 DERIVED

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

  CUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 16, 2016
• Study Start: January 24, 2017
• Primary Completion: February 7, 2020
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (2)