CompletedNot Applicable

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

Indonesia8 participantsStarted 2026-06-14

Plain-language 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

Who can participate

Age range

3 Days – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Salivary Cortisol Level

Timeframe: Baseline (Day 1) and Day 14

mother-infant interaction

Timeframe: Baseline (Day 1) and Day 14

Trial details

NCT IDNCT07728760

SponsorGadjah Mada University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

View on ClinicalTrials.gov More Preterm Infant trials