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Clinical Trials/CTRI/2025/12/098355
CTRI/2025/12/098355
Not yet recruiting
Not Applicable

The Feasibility of Implementing SENSE Program for Preterm Infants in the Neonatal Intensive Care Unit (NICU) In Public Hospital at Mumbai: A Pilot Study

Non sponser1 site in 1 country20 target enrollmentStarted: December 15, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Non sponser
Enrollment
20
Locations
1
Primary Endpoint
APIB

Overview

Brief Summary

TITLE:

The Feasibility of Implementing SENSE Program for Preterm Infants In The Neonatal Intensive Care Unit (NICU) In Public Hospital At Mumbai: A Pilot Study

RATIONALE:

Preterm birth is associated with a range of neurodevelopmental challenges, including cognitive, motor, and sensory impairments. The NICU environment, while necessary for medical care, can be overwhelming and stressful for infants potentially disrupting their development. To address these challenges, the SENSE program was developed as a non-pharmacological intervention by providing developmentally appropriate sensory experiences. But there are limited studies showing the effect of SENSE program in neurodevelopmental and feeding outcomes in preterm infants. Presently, it is not used in our tertiary care hospital.  Before making it as Standard of Care, we would like to know the feasibility of SENSE program in Public Hospital at Mumbai.

 AIM OF THE STUDY:

To evaluate the feasibility of implementing SENSE Program to increase positive sensory exposure for infants born preterm, support neonatal neurodevelopment, and increase maternal confidence.

OBJECTIVES:

1.Administration of SENSE program in tertiary care hospital from admission of the eligible candidate in the NICU.

  1. To evaluate preterm infants by using APIB before and after the administration of SENSE.

3.To evaluate outcome of preterm infants by using a standardized scale Hammersmith Neonatal Neurological Examination(HNNE) at NICU in 37 – 40 weeks.

4.  To evaluate parent-infant attachment and parental stress levels by using Maternal Confidence Questionnaire pre and post administration of SENSE .

5.To analyze a qualitative feedback from nurses of NICU.

 METHODOLOGY:

Study Design: Pilot study.

Study Duration: 18 months

Study Setting: Data

Sampling Technique: Purposive Sampling

Sample Size: As this is a Pilot Study, the sample size would be 20.

INCLUSION CRITERIA:

  1. Preterm infants admitted at NICU whose gestational age less than 37 weeks .
  2. Newly admitted infants
  3. Both male and female infants.

 EXCLUSION CRITERIA:

  1. Infants born with congenital anomalies ( Downs syndrome, spina bifida ,cleft palate , etc.)
  2. Parents having any other psychiatry condition, neurological condition or any other disability

 DATA COLLECTION:

Permissions: After IEC approval,

  1. Participants will be recruited based on inclusion and exclusion criteria.

  2. Consent /assent will be taken from caregivers.

In this study there will be a single group, pre-post experimental study design

Data Gathering: Data will be collected from patients admitted in NICU.

Assessment will be done using: 1.APIB(Assessment of preterm infant behaviour)

2.Maternal confidence questionnaire

SENSE program will be administered by

·       Individualized approach

·       Family centered approach

Ø  Parents will be provided weekly log books in which they will be asked questions such as amount of sensory exposures, by whom sensory exposures was given.

Ø  During the study,a qualitative feedback will be taken from nurses.

Ø  Just prior to discharge or on term age, HNNE will be administered as an outcome measure.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
1.00 Day(s) to 3.00 Month(s) (—)
Sex
All

Inclusion Criteria

  • Preterm infants admitted at NICU whose gestational age less than 37 weeks .
  • Newly admitted infants
  • Both male and female infants.

Exclusion Criteria

  • Infants born with congenital anomalies ( Downs syndrome, spina bifida ,cleft palate , etc.)
  • Parents having any other psychiatry condition, neurological condition or any other disability.

Outcomes

Primary Outcomes

APIB

Time Frame: during discharge from NICU

Hammersmith Neonatal Neurological Examination

Time Frame: during discharge from NICU

• Maternal Confidence Questionnaire

Time Frame: during discharge from NICU

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Non sponser
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Hemant Nandgaonkar

Occupational Therapy School and Centre, Seth GSMC and KEM Hospital

Study Sites (1)

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