Pilot Study of the SENSITIVE Care Program for Preterm Infants in the Neonatal Intensive Care Unit | NCT07728760

NCT07728760

Overview

NCT ID: NCT07728760
Lead Sponsor: Gadjah Mada UniversityOTHER
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
Brief 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:

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

Status and Timeline

Status: Completed
Last Update Posted: Jul 27, 2026Actual
Start Date: Jun 14, 2026Actual
Primary Completion Date: Jul 15, 2026Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Child (0-17)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Type: Interventional
Phase: Not Applicable
Enrollment: 8Actual
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: RSUD Wates, Daerah Istimewa Yogyakarta, Indonesia

Similar Studies

Participant Group/Arms

SENSITIVE Care ProgramExperimental

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

Standard Neonatal Intensive CareActive Comparator

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