Randomized controlled trial of Family Nurture Intervention in the NICU: assessments of length of stay, feasibility and safety

BMC Pediatrics

Michael M Myers⁴  Robert J Ludwig³  Sara B Glickstein²  Judy Austin¹  Howard F Andrews¹  Raymond I Stark⁵  Myron A Hofer⁴  Martha G Welch⁴ 

[1] Mailman School of Public Health, Columbia University, New York, NY, USA;EB Sciences, Oakland, CA, USA;Department of Psychiatry, Columbia University College of Physicians & Surgeons, New York, NY, USA;Department of Developmental Neuroscience, New York State Psychiatric Institute, 1051 Riverside Drive, Unit 40, New York, NY, 10032, USA;Department of Pediatrics, Columbia University College of Physicians & Surgeons, New York, NY, USA

关键词: Length of stay;    Feasibility;    Safety;    Nurture;    NICU;    Premature infant;   

Others  :  1144497
DOI  :  10.1186/1471-2431-13-148

 received in 2013-02-22, accepted in 2013-09-18,  发布年份 2013

【 摘 要 】

Background

While survival rates for preterm infants have increased, the risk for adverse long-term neurodevelopmental and behavioral outcomes remains very high. In response to the need for novel, evidence-based interventions that prevent such outcomes, we have assessed Family Nurture Intervention (FNI), a novel dual mother-infant intervention implemented while the infant is in the Neonatal Intensive Care Unit (NICU). Here, we report the first trial results, including the primary outcome measure, length of stay in the NICU and, the feasibility and safety of its implementation in a high acuity level IV NICU.

Methods

The FNI trial is a single center, parallel-group, randomized controlled trial at Morgan Stanley Children’s Hospital for mothers and their singleton or twin infants of 26–34 weeks gestation. Families were randomized to standard care (SC) or (FNI). FNI was implemented by nurture specialists trained to facilitate affective communication between mother and infant during specified calming interactions. These interactions included scent cloth exchange, sustained touch, vocal soothing and eye contact, wrapped or skin-to-skin holding, plus family-based support interactions.

Results

A total of 826 infants born between 26 and 34 weeks during the 3.5 year study period were admitted to the NICU. After infant and mother screening plus exclusion due to circumstances that prevented the family from participating, 373 infants were eligible for the study. Of these, we were unable to schedule a consent meeting with 56, and consent was withheld by 165. Consent was obtained for 150 infants from 115 families. The infants were block randomized to groups of N = 78, FNI and N = 72, SC. Sixteen (9.6%) of the randomized infants did not complete the study to home discharge, 7% of those randomized to SC and 12% of FNI infants. Mothers in the intervention group engaged in 3 to 4 facilitated one- to two-hour sessions/week. Intent to treat analyses revealed no significant difference between groups in medical complications. The mean length of stay was not significantly affected by the intervention.

Conclusion

There was no significant effect demonstrated with this intervention amount on the primary short-term outcome, length of stay. FNI can be safely and feasibly implemented within a level IV NICU.

Trial registration

Clinicaltrials.gov: NCT01439269

【 授权许可】

   
2013 Welch et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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