Purpose

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 two-part study aims to: - Part I - 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 - if enrollment not reached, enrollment may continue in Part II - Part II - examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention. - FNI, approximately 90 infants plus their parents

Conditions

Eligibility

Eligible Ages
Between 26 Weeks and 34 Weeks
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard Care
Preterm infants will receive current Standard Care (SC) in the NICU.
  • Behavioral: Standard Care
    Established routine care provided on the NICU floor by specially trained health care professionals.
    Other names:
    • SC
Experimental
Intervention
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
    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.
    Other names:
    • FNI
  • Behavioral: Standard Care
    Established routine care provided on the NICU floor by specially trained health care professionals.
    Other names:
    • SC
Active Comparator
Term Controls
Full term infants will receive current Standard Care (SC) in the NICU. Term Controls (TC)
  • Behavioral: Standard Care
    Established routine care provided on the NICU floor by specially trained health care professionals.
    Other names:
    • SC

Recruiting Locations

University Texas Health Science Center San Antonio (UTHSCSA)
San Antonio, Texas 78229
Contact:
Alice K Gong, MD
gong@uthscsa.edu

More Details

NCT ID
NCT02710474
Status
Recruiting
Sponsor
Columbia University

Study Contact

Mai Mitsuyama, BA
(212) 342-4400
mm4584@cumc.columbia.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.