Clinical Trial

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

Study acronym: SENSITIVE Care
Completed
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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
Trial Details
NCT Number NCT07728760
Lead Sponsor Gadjah Mada University
Conditions Preterm Infant, Infant, Premature, Neonatal Intensive Care Unit (NICU)
Enrollment 8 participants
Start Date 2026-06-14
Primary Completion 2026-07-15 (estimated)
Study Completion 2026-07-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-27