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

NCT07728760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-07-27

No results posted yet for this study

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

Conditions

  • Preterm Infant
  • Infant, Premature
  • Neonatal Intensive Care Unit (NICU)

Interventions

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.

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.

Sponsors & Collaborators

  • Gadjah Mada University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Days
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-14
Primary Completion
2026-07-15
Completion
2026-07-22

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728760 on ClinicalTrials.gov