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Preterm InfantSENSITIVE CareNCT07728760

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

A study testing SENSITIVE Care Program and Standard Neonatal Intensive Care in people with Preterm Infant and Infant, Premature, run by Gadjah Mada University at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 28 days
What is being tested?
SENSITIVE Care Program and Standard Neonatal Intensive Care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteIndonesia
Study dates
14 Jun 2026to 22 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • Major congenital anomalies, chromosomal abnormalities, or genetic syndromes. Congenital oral or facial anomalies interfering with salivary cortisol collection.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • RSUD Wates, Daerah Istimewa Yogyakarta, Indonesia

    Bantul, DI. Yogyajarta, 55714

Other trials in Indonesia

About this study

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

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:

Read more
  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
Read the detailed description

The Sensory Integrative Intervention (SENSITIVE) Care Program was developed as a complex developmental care intervention to provide individualized, family-centered support for preterm infants admitted to the Neonatal Intensive Care Unit (NICU). The intervention was designed in response to the limited availability of standardized developmental care programs that integrate multiple sensory modalities while adapting intervention intensity according to each infant's physiological and behavioral readiness.

The development of the SENSITIVE Care Program followed the Medical Research Council (MRC) Framework for Developing and Evaluating Complex Interventions. Intervention development consisted of sequential stages, including evidence synthesis through a scoping review, qualitative exploration of the experiences and needs of mothers and NICU healthcare professionals, consultation with multidisciplinary experts, and refinement of intervention materials before clinical implementation. This process ensured that the intervention was evidence-informed, clinically feasible, culturally appropriate, and suitable for integration into routine neonatal practice.

The conceptual framework of the program combines developmental care principles, Family-Centered Care, Synactive Theory of Development, Attachment Theory, and evidence supporting early parental participation during NICU hospitalization. Collectively, these approaches recognize that individualized sensory experiences, when delivered according to infant readiness, may support physiological regulation while strengthening early parent-infant relationships.

Unlike conventional developmental care interventions that frequently provide similar sensory activities to all infants, the SENSITIVE Care Program individualizes intervention delivery according to each infant's readiness for sensory stimulation. Readiness is determined through structured assessment of physiological stability, behavioral organization, tolerance to handling, and readiness for parent participation before each intervention session. This assessment guides healthcare professionals in selecting the appropriate level and progression of sensory activities while minimizing the risk of overstimulation.

The readiness-based implementation algorithm classifies infants into four progressive readiness categories. Level 1 focuses on physiological stabilization through environmental modification, containment, and minimal handling for infants who demonstrate limited tolerance to stimulation. Level 2 introduces early sensory experiences using gentle therapeutic touch, maternal voice, and familiar maternal scent when infants demonstrate improved physiological stability. Level 3 emphasizes supported parental participation through therapeutic touch, kangaroo mother care, and responsive interaction as infants become increasingly tolerant of sensory input. Level 4 promotes integrated multisensory developmental care by combining tactile, auditory, visual, vestibular, and parent-infant interaction activities according to individual developmental readiness and clinical stability. Progression between levels is individualized and depends on continuous reassessment rather than predetermined chronological timing.

The intervention integrates multiple evidence-informed sensory components into a single structured developmental care program. These components include environmental modification to reduce unnecessary sensory stress, therapeutic touch, positioning support, maternal voice exposure, visual interaction when developmentally appropriate, skin-to-skin care, facilitation of parent participation during routine caregiving, and structured parent education. Rather than functioning as isolated interventions, these components are delivered as complementary elements of an integrated developmental care strategy designed to support infant neurobehavioral organization while promoting parental confidence and engagement.

A distinguishing feature of the SENSITIVE Care Program is the structured coaching provided to mothers by trained NICU nurses. Nurses guide parents in recognizing infant behavioral cues, identifying signs of physiological stability and stress, responding appropriately to infant communication, and participating safely in developmental care activities. This coaching process aims to strengthen parental competence, improve responsive caregiving, and facilitate continuity of developmental care during hospitalization and after discharge.

Intervention delivery is individualized for each participant. Decisions regarding the selection, timing, progression, and intensity of sensory activities are based on ongoing assessment of infant readiness, current medical condition, behavioral responses, and parental participation. Temporary modification or postponement of intervention activities is permitted whenever clinical instability or behavioral stress responses are observed, ensuring that developmental care remains responsive to the infant's changing condition.

To promote intervention fidelity, implementation is supported by a standardized intervention manual, structured educational materials, competency-based nurse training, readiness assessment guidelines, intervention documentation forms, and fidelity monitoring procedures. Healthcare professionals receive standardized preparation before intervention delivery to ensure consistent implementation while preserving the flexibility required for individualized developmental care. Adherence to the intervention protocol is monitored throughout the study using standardized implementation checklists and periodic supervision.

The SENSITIVE Care Program has been designed to complement existing NICU practice rather than replace routine neonatal care. Its structured yet flexible implementation strategy enables integration into routine clinical workflows while encouraging interdisciplinary collaboration and active family participation. By combining individualized sensory progression, standardized implementation procedures, and structured parental coaching within a family-centered developmental care framework, the program addresses several limitations of existing developmental care models.

This study is expected to contribute to the growing evidence supporting readiness-based developmental care for preterm infants and to inform future implementation of standardized family-centered sensory interventions in NICU settings. The findings may also support wider adoption of structured developmental care programs that are feasible for implementation across hospitals with varying levels of neonatal care resources.

Being tested
SENSITIVE Care Program, Standard Neonatal Intensive Care
Keywords
preterm infant, developmental care, Family-Centered Care, Sensory Integrative Intervention for Preterm Infants, Sensory Stimulation, Parent Participation, Kangaroo Mother Care, Mother-Infant Interaction, Salivary Cortisol, Neurodevelopment, Neonatal Intensive Care Unit
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SENSITIVE Care ProgramBehavioural

    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 CareOther

    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.

Study groups in NCT07728760
Study groupRoleWhat they receive
SENSITIVE Care ProgramExperimentalPreterm 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.
Receives: Behavioral: SENSITIVE Care Program
Standard Neonatal Intensive CareActive comparatorPreterm 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.
Receives: Other: Standard Neonatal Intensive Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Salivary Cortisol Level

    Change in salivary cortisol concentration measured using enzyme-linked immunosorbent assay (ELISA) to evaluate physiological stress in preterm infants.

    Measured: Baseline (Day 1) and Day 14

  2. mother-infant interaction

    Change in mother-infant interaction assessed using the Mother-Infant Bonding Scale-Indonesia (MIBS-I).

    Measured: Baseline (Day 1) and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2026
  2. Study start14 Jun 2026
  3. Primary completion15 Jul 2026
  4. Study completion22 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
This is a two-arm, nonrandomized quasi-experimental pilot study with a parallel assignment design. Eligible preterm infants will be allocated to either the SENSITIVE Care Program plus standard neonatal intensive care or standard neonatal intensive care alone. The SENSITIVE Care Program will be delivered over a 14-day intervention period. Both groups will be followed concurrently to evaluate the feasibility, acceptability, and implementation fidelity of the intervention and to explore its preliminary effects on salivary cortisol levels and mother-infant interaction.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07728760
Sponsor's protocol ID
69965c7ac5eaf
Acronym
SENSITIVE Care
Status last verified
Jul 2026
First submitted
22 Jul 2026
Last updated
27 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared because the study involves a vulnerable population (preterm infants), and the informed consent and ethics approval do not include provisions for public data sharing.

Questions about this trial

What is this clinical trial studying?

A study testing SENSITIVE Care Program and Standard Neonatal Intensive Care in people with Preterm Infant and Infant, Premature, run by Gadjah Mada University at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Salivary Cortisol Level (time frame: Baseline (Day 1) and Day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.

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