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Lay Description

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

Category

IRB Number
20160471HU
NCT Number
NCT02710474
Open to Enrollment
No

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

Arm Groups

Study Contact


Diana Anzueto Guerra
(210) 567-5225
anzuetod@uthscsa.edu

Alice Gong
(210) 567-5227
gong@uthscsa.edu

Diana Anzueto Guerra
(210) 567-5225
anzuetod@uthscsa.edu

Principal Investigator
Alice Gong