Department of Psychiatry, Columbia University College of Physicians & Surgeons, New York, NY, USA.
BMC Pediatr. 2013 Sep 24;13:148. doi: 10.1186/1471-2431-13-148.
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.
尽管早产儿的存活率有所提高，但他们仍存在发生长期神经发育和行为不良后果的高风险。为了寻找新的、基于证据的干预措施来预防这些后果，我们评估了家庭培育干预（FNI），这是一种新的母婴双重干预措施，在新生儿重症监护病房（NICU）中对婴儿进行。在这里，我们报告了首次试验结果，包括主要结局指标，NICU 住院时间，以及在高难度四级 NICU 中实施的可行性和安全性。
FNI 试验是在摩根斯坦利儿童医院进行的一项单中心、平行组、随机对照试验，研究对象为 26-34 周妊娠的母亲及其单胎或双胞胎婴儿。家庭被随机分配到标准护理（SC）或（FNI）。FNI 由受过培训的培育专家实施，旨在促进母亲和婴儿在特定的平静互动期间进行情感沟通。这些互动包括气味布交换、持续触摸、声音安抚和眼神接触、包裹或皮肤对皮肤的握持，以及基于家庭的支持互动。
在 3.5 年的研究期间，共有 826 名 26-34 周出生的婴儿在 NICU 接受治疗。经过婴儿和母亲的筛选，以及由于某些情况使家庭无法参与而被排除在外后，共有 373 名婴儿符合研究条件。在这些婴儿中，我们无法与 56 名婴儿的家庭安排同意会议，165 名家庭拒绝同意。150 名婴儿的 115 个家庭同意参加研究。这些婴儿被随机分组，每组 N=78，FNI 和 N=72，SC。16 名（9.6%）随机分配的婴儿没有完成出院回家的研究，7%的随机分配到 SC 组，12%的 FNI 婴儿。干预组的母亲每周进行 3 到 4 次 1 到 2 小时的促进性会议。意向治疗分析显示，两组在医疗并发症方面没有显著差异。干预组的平均住院时间没有受到显著影响。
这种干预量对主要短期结局（住院时间）没有显著效果。FNI 可以安全、可行地在四级 NICU 中实施。
Clinicaltrials.gov：NCT01439269。
