CompletedNot Applicable

Family Nurture Intervention in the NICU at The Valley Hospital

United States150 participantsStarted 2017-10-20

Plain-language summary

The purpose of this study is to compare neurodevelopment and activity in infants born preterm (25 to 34 1/7 weeks gestational age (GA)) receiving Standard Care (SC) or Family Nurture Intervention (FNI) in the neonatal intensive care unit (NICU). The investigators hypothesize 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-phase effectiveness study aims to: * Phase 1 - Examine the existing Standard Care Approximately 35 infants and their mothers * Phase 2 - Examine effectiveness by implementing FNI unit-wide so that every baby receives the intervention Approximately 35 infants and their mothers

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 Standard Care and FNI Groups 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

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

EEG Power in the frontal polar region

Timeframe: Up to 41 weeks gestational age

Trial details

NCT IDNCT03267043

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-03-19

View on ClinicalTrials.gov More Premature Birth trials