Pilot Study of the Effectiveness of the SENSITIVE Care Program on Salivary Cortisol Levels and Mother-Infant Interaction in Preterm Infants Admitted to the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Salivary Cortisol Level
研究概览
简要总结
The goal of this clinical trial is to learn whether the Sensory Integrative Intervention (SENSITIVE) Care Program helps reduce stress and improve mother-infant interaction in preterm infants receiving care in the Neonatal Intensive Care Unit (NICU).
The main questions it aims to answer are:
- Does the SENSITIVE Care Program lower stress in preterm infants, measured by saliva cortisol levels?
- Does the SENSITIVE Care Program improve the interaction between mothers and their preterm infants?
Researchers will compare preterm infants who receive the SENSITIVE Care Program together with standard NICU care with preterm infants who receive standard NICU care alone to see if the program works better than standard care alone.
Participants will:
- Receive either the SENSITIVE Care Program together with standard NICU care or standard NICU care alone.
- Take part in a 14-day program that includes touch, skin-to-skin care (kangaroo mother care), talking and voice mother to the baby, eye contact when appropriate, and other sensory activities based on the baby's readiness and medical condition.
- Provide saliva samples to measure cortisol levels.
- Have their interaction with their mother, pain, vital signs, feeding and weight gain
详细描述
The Sensory Integrative Intervention (SENSITIVE) Care Program was developed as a complex developmental care intervention to provide individualized, family-centered support for preterm infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention was designed in response to the limited availability of standardized developmental care programs that integrate multiple sensory modalities while adapting intervention intensity according to each infant's physiological and behavioral readiness.
The development of the SENSITIVE Care Program followed the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. Intervention development consisted of sequential stages, including evidence synthesis through a scoping review, qualitative exploration of the experiences and needs of mothers and NICU healthcare professionals, consultation with multidisciplinary experts, and refinement of intervention materials before clinical implementation. This process ensured that the intervention was evidence-informed, clinically feasible, culturally appropriate, and suitable for integration into routine neonatal practice.
The conceptual framework of the program combines developmental care principles, Family-Centered Care, Synactive Theory of Development, Attachment Theory, and evidence supporting early parental participation during NICU hospitalization. Collectively, these approaches recognize that individualized sensory experiences, when delivered according to infant readiness, may support physiological regulation while strengthening early parent-infant relationships.
Unlike conventional developmental care interventions that frequently provide similar sensory activities to all infants, the SENSITIVE Care Program individualizes intervention delivery according to each infant's readiness for sensory stimulation. Readiness is determined through structured assessment of physiological stability, behavioral organization, tolerance to handling, and readiness for parent participation before each intervention session. This assessment guides healthcare professionals in selecting the appropriate level and progression of sensory activities while minimizing the risk of overstimulation.
The readiness-based implementation algorithm classifies infants into four progressive readiness categories. Level 1 focuses on physiological stabilization through environmental modification, containment, and minimal handling for infants who demonstrate limited tolerance to stimulation. Level 2 introduces early sensory experiences using gentle therapeutic touch, maternal voice, and familiar maternal scent when infants demonstrate improved physiological stability. Level 3 emphasizes supported parental participation through therapeutic touch, kangaroo mother care, and responsive interaction as infants become increasingly tolerant of sensory input. Level 4 promotes integrated multisensory developmental care by combining tactile, auditory, visual, vestibular, and parent-infant interaction activities according to individual developmental readiness and clinical stability. Progression between levels is individualized and depends on continuous reassessment rather than predetermined chronological timing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants (parents) and NICU healthcare providers were aware of the assigned intervention because of the nature of the SENSITIVE care program. Investigators were aware of treatment allocation but were not involved in delivering the intervention. Mother-infant interaction was evaluated by independent outcome assessors who were unaware of group assignment. Salivary cortisol samples were labeled with unique identification codes before laboratory analysis, and laboratory personnel remained blinded to treatment allocation.
入排标准
- 年龄范围
- 3 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born at 28 to <37 weeks of gestation, Admitted to one of the participating NICUs, Chronological age of 3 days or older at enrollment, Clinically stable as determined by the attending neonatologist, Expected to remain hospitalized for at least 14 days, Parent or legal guardian provided written informed consent.
排除标准
- •Major congenital anomalies, chromosomal abnormalities, or genetic syndromes. Congenital oral or facial anomalies interfering with salivary cortisol collection.
结局指标
主要结局
Salivary Cortisol Level
时间窗: Baseline (Day 1) and Day 14
Change in salivary cortisol concentration measured using enzyme-linked immunosorbent assay (ELISA) to evaluate physiological stress in preterm infants.
mother-infant interaction
时间窗: Baseline (Day 1) and Day 14
Change in mother-infant interaction assessed using the Mother-Infant Bonding Scale-Indonesia (MIBS-I).
次要结局
未报告次要终点
研究者
Zulia Putri Perdani
Doctoral Candidate
Gadjah Mada University