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 range
26 Weeks – 34 Weeks
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
EEG Power in the frontal polar region
Timeframe: Infant Age at 39-41 Weeks gestational age