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Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit
Sponsor: Gadjah Mada University
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
3 Days - 28 Days
Study Type
INTERVENTIONAL
Enrollment
8
Start Date
2026-06-14
Completion Date
2026-07-22
Last Updated
2026-07-27
Healthy Volunteers
No
Interventions
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.
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.
Locations (1)
RSUD Wates, Daerah Istimewa Yogyakarta, Indonesia
Bantul, DI. Yogyajarta, Indonesia