Family Nurture Intervention in the NICU (NCT02710474) | Clinical Trial Compass
CompletedNot Applicable
Family Nurture Intervention in the NICU
United States461 participantsStarted 2017-01-24
Plain-language 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
Who can participate
Age range26 Weeks – 34 Weeks
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For the FNI and SC Groups (enrolled competitively at across all participating sites)
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 ha…
What they're measuring
1
EEG Power in the frontal polar region
Timeframe: Infant Age at 39-41 Weeks gestational age