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

ABSTRACT: 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.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.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.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.Clinicaltrials.gov: NCT01439269.

SUBMITTER: Welch MG

PROVIDER: S-EPMC3851000 | biostudies-literature | 2013 Sep

REPOSITORIES: biostudies-literature

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

Welch Martha G MG Hofer Myron A MA Stark Raymond I RI Andrews Howard F HF Austin Judy J Glickstein Sara B SB Ludwig Robert J RJ Myers Michael M MM

BMC pediatrics 20130924

<h4>Background</h4>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 ...[more]

PMID: 24063360

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Project description:The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU) can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges.This study is a randomized controlled trial (RCT) with blinded assessment comparing Standard Care (SC) with a novel Family Nurture Intervention (FNI). FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA) and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1) In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2) Outside the isolette during holding and feeding via the Calming Cycle; and 3) through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA), maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group).The FNI is designed to increase biologically important activities and behaviors that enhance maternally-mediated sensory experiences of preterm infants, as well as infant-mediated sensory experiences of the mother. Consequently, we are enlarging the testing of preterm infant neurodevelopment beyond that of previous research to include outcomes related to mother-infant interactions and mother-infant co-regulation. Our primary objective is to determine whether repeated engagement of the mother and her infant in the intervention's calming activities will improve the infant's developmental trajectory with respect to multiple outcomes. Our secondary objective is to assess the effectiveness of FNI in the physiological and psychological co-regulation of the mother and infant. We include aspects of neurodevelopment that have not been comprehensively measured in previous NICU interventions.ClinicalTrials.gov: NCT01439269.

Project description:Performance measures, particularly pay for performance, may have unintended consequences for safety-net institutions caring for disproportionate shares of Medicaid or uninsured patients.To describe emergency department (ED) compliance with proposed length-of-stay measures for admissions (8 hours or 480 minutes) and discharges, transfers, and observations (4 hours or 240 minutes) by safety-net status.The 2008 National Hospital Ambulatory Medical Care Survey (NHAMCS) ED data were stratified by safety-net status (Centers for Disease Control and Prevention definition) and disposition (admission, discharge, observation, transfer). The 2008 NHAMCS is a national probability sample of 396 hospitals (90.2% unweighted response rate) and 34 134 patient records. Visits were excluded for patients younger than 18 years, missing length-of-stay data or dispositions of missing, other, left against medical advice, or dead on arrival. Median and 90th percentile ED lengths of stay were calculated for each disposition and admission/discharge subcategories (critical care, psychiatric, routine) stratified by safety-net status. Multivariable analyses determined associations with length-of-stay measure compliance.Emergency Department length-of-stay measure compliance by disposition and safety-net status.Of the 72.1% ED visits (N = 24 719) included in the analysis, 42.3% were to safety-net EDs and 57.7% were to non-safety-net EDs. The median length of stay for safety-net was 269 minutes (interquartile range [IQR], 178-397 minutes) for admission vs 281 minutes (IQR, 178-401 minutes) for non-safety-net EDs; 156 minutes (IQR, 95-239 minutes) for discharge vs 148 minutes (IQR, 88-238 minutes); 355 minutes (IQR, 221-675 minutes) for observations vs 298 minutes (IQR, 195-440 minutes); and 235 minutes (IQR, 155-378 minutes) for transfers vs 239 minutes (IQR, 142-368 minutes). Safety-net status was not independently associated with compliance with ED length-of-stay measures; the odds ratio was 0.83 for admissions (95% CI, 0.52-1.34); 1.03 for discharges (95% CI, 0.83-1.27); 1.05 for observations (95% CI, 0.57-1.95), 1.30 for transfers (95% CI, 0.70-2.45]); or subcategories except for psychiatric discharges (1.67, [95% CI, 1.02-2.74]).Compliance with proposed ED length-of-stay measures for admissions, discharges, transfers, and observations did not differ significantly between safety-net and non-safety-net hospitals.

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

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

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