NCT03267043

Family Nurture Intervention in the NICU at The Valley Hospital

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 26 Weeks – 34 Weeks
• Healthy volunteers: Not accepted

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

Detailed description

This study aims to build upon the findings of the earlier randomized controlled trial (RCT) conducted at the Columbia University Medical Center (CUMC) comparing effects, both physiological and emotional, of the current standard method of encouraging contact between mothers and their babies in the NICU with the more specific approach of Family Nurture Intervention (FNI). In addition to receiving standard care, NICU families assigned to FNI received added intervention that focused on supporting the parents and facilitating emotional connection between mother and infant during the infant's NICU stay. The investigators wish to conduct an effectiveness trial to evaluate if the family nurture intervention's findings can be replicated on a unit-wide level. This effectiveness trial will take place over two parts. There will be two groups; standard care (SC) and intervention (FNI). Phase 1 of the effectiveness study will evaluate the standard care (SC) group in the unit as a baseline measurement and point of comparison to determine if unit-wide FNI reproduces its prior findings (Phase 2). The standard care group (Phase 1) will receive the current standard of care in the NICU. In Phase 2, FNI will be implemented unit-wide, but infants born between 26 weeks and 0 days to 33 weeks 6 days gestation will be eligible to be enrolled into the study. In addition to receiving standard care, patients enrolled during phase 2 will receive added interventions from the trained FNI nursing staff. These added interventions will include supporting the parents and facilitating contact between mother and infant during their infant's NICU stay.

Conditions

• Premature Birth
• Obstetric Labor, Premature

Interventions

Type	Name	Description
BEHAVIORAL	Family Nurture Intervention (FNI)	Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
BEHAVIORAL	Standard Care	Established routine care provided on the NICU floor by specially trained health care professionals.

Timeline

• Start date: 2017-10-20
• Primary completion: 2020-03-19
• Completion: 2020-07-01
• First posted: 2017-08-30
• Last updated: 2023-02-15

Locations

2 sites across 1 country: United States