Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit (SENSITIVE Care)

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

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:

1. Does the SENSITIVE Care Program lower stress in preterm infants, measured by saliva cortisol levels?
2. 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:

1. Receive either the SENSITIVE Care Program together with standard NICU care or standard NICU care alone.
2. 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.
3. Provide saliva samples to measure cortisol levels.
4. Have their interaction with their mother, pain, vital signs, feeding and weight gain

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Infant, Premature; Neonatal Intensive Care Unit (NICU)
• Intervention / Treatment: Behavioral: SENSITIVE Care Program; Other: Standard Neonatal Intensive Care

Detailed Description

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.

The intervention integrates multiple evidence-informed sensory components into a single structured developmental care program. These components include environmental modification to reduce unnecessary sensory stress, therapeutic touch, positioning support, maternal voice exposure, visual interaction when developmentally appropriate, skin-to-skin care, facilitation of parent participation during routine caregiving, and structured parent education. Rather than functioning as isolated interventions, these components are delivered as complementary elements of an integrated developmental care strategy designed to support infant neurobehavioral organization while promoting parental confidence and engagement.

A distinguishing feature of the SENSITIVE Care Program is the structured coaching provided to mothers by trained NICU nurses. Nurses guide parents in recognizing infant behavioral cues, identifying signs of physiological stability and stress, responding appropriately to infant communication, and participating safely in developmental care activities. This coaching process aims to strengthen parental competence, improve responsive caregiving, and facilitate continuity of developmental care during hospitalization and after discharge.

Intervention delivery is individualized for each participant. Decisions regarding the selection, timing, progression, and intensity of sensory activities are based on ongoing assessment of infant readiness, current medical condition, behavioral responses, and parental participation. Temporary modification or postponement of intervention activities is permitted whenever clinical instability or behavioral stress responses are observed, ensuring that developmental care remains responsive to the infant's changing condition.

To promote intervention fidelity, implementation is supported by a standardized intervention manual, structured educational materials, competency-based nurse training, readiness assessment guidelines, intervention documentation forms, and fidelity monitoring procedures. Healthcare professionals receive standardized preparation before intervention delivery to ensure consistent implementation while preserving the flexibility required for individualized developmental care. Adherence to the intervention protocol is monitored throughout the study using standardized implementation checklists and periodic supervision.

The SENSITIVE Care Program has been designed to complement existing NICU practice rather than replace routine neonatal care. Its structured yet flexible implementation strategy enables integration into routine clinical workflows while encouraging interdisciplinary collaboration and active family participation. By combining individualized sensory progression, standardized implementation procedures, and structured parental coaching within a family-centered developmental care framework, the program addresses several limitations of existing developmental care models.

This study is expected to contribute to the growing evidence supporting readiness-based developmental care for preterm infants and to inform future implementation of standardized family-centered sensory interventions in NICU settings. The findings may also support wider adoption of structured developmental care programs that are feasible for implementation across hospitals with varying levels of neonatal care resources.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DI. Yogyajarta
    • Bantul, DI. Yogyajarta, Indonesia, 55714
      • RSUD Wates, Daerah Istimewa Yogyakarta, Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Major congenital anomalies, chromosomal abnormalities, or genetic syndromes. Congenital oral or facial anomalies interfering with salivary cortisol collection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SENSITIVE Care Program; Preterm infants admitted to the intervention hospital received the SENSITIVE Care Program in addition to standard neonatal intensive care. The intervention was delivered over a 14-day period using a structured, readiness-based sensory integrative care approach that actively involved parents while continuing routine NICU care.	Behavioral: SENSITIVE Care Program; The SENSITIVE Care Program is a structured, readiness-based sensory integrative intervention designed for preterm infants admitted to the NICU. The program is delivered over a 14-day period by trained NICU nurses in collaboration with parents, in addition to routine neonatal intensive care. The intervention integrates individualized sensory stimulation based on the infant's behavioral and physiological readiness, developmental supportive care, kangaroo mother care, positive touch, parental engagement, and responsive parent-infant interaction. Intervention activities are tailored according to the infant's clinical stability and readiness to promote physiological regulation, reduce stress, and support early mother-infant interaction.
Active Comparator: Standard Neonatal Intensive Care; Preterm infants admitted to the control hospital received routine neonatal intensive care according to the hospital's standard clinical practice for the same 14-day study period. Participants in this arm did not receive the SENSITIVE Care Program.	Other: Standard Neonatal Intensive Care; Preterm infants admitted to the control hospital received routine neonatal intensive care according to the hospital's standard clinical practice for the same 14-day study period. Participants in this arm did not receive the SENSITIVE Care Program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Cortisol Level	Change in salivary cortisol concentration measured using enzyme-linked immunosorbent assay (ELISA) to evaluate physiological stress in preterm infants.	Baseline (Day 1) and Day 14
mother-infant interaction	Change in mother-infant interaction assessed using the Mother-Infant Bonding Scale-Indonesia (MIBS-I).	Baseline (Day 1) and Day 14

Collaborators and Investigators

• Sponsor: Gadjah Mada University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2026
• Primary Completion (Actual): July 15, 2026
• Study Completion (Actual): July 22, 2026

Study Registration Dates

• First Submitted: July 22, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Neurodevelopment; preterm infant; Salivary Cortisol; Family-Centered Care; Neonatal Intensive Care Unit; developmental care; Kangaroo Mother Care; Sensory Stimulation; Mother-Infant Interaction; Sensory Integrative Intervention for Preterm Infants; Parent Participation
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 69965c7ac5eaf

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because the study involves a vulnerable population (preterm infants), and the informed consent and ethics approval do not include provisions for public data sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No