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临床试验/CTRI/2025/12/098355
CTRI/2025/12/098355尚未招募不适用

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 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
APIB

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
1.00 Day(s) 至 3.00 Month(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

APIB

时间窗: during discharge from NICU

Hammersmith Neonatal Neurological Examination

时间窗: during discharge from NICU

• Maternal Confidence Questionnaire

时间窗: during discharge from NICU

次要结局

未报告次要终点

研究者

发起方
Non sponser
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Hemant Nandgaonkar

Occupational Therapy School and Centre, Seth GSMC and KEM Hospital

研究点 (1)

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