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 range26 Weeks – 34 Weeks

SexALL

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

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