Family Nurture Intervention in the NICU
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