跳至主要内容
临床试验/CTRI/2025/10/096604
CTRI/2025/10/096604尚未招募不适用

Effectiveness of m-Health application "Sishu Suraksha" on maternal knowledge, satisfaction with home care practices and clinical outcomes, growth and development of high-risk neonates following NICU discharge from a selected tertiary care hospital: A randomized controlled trial

Siksha O Anusandhan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年12月1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
120
试验地点
1
主要终点
Maternal knowledge, satisfaction, neonatal clinical outcomes, growth and development

研究概览

简要总结

mHealth intervention is a web-based application for healthcare services in remote areas through interaction with healthcare professionals by enriching the network with the mothers and healthcare providers. Through the app, mothers of high-risk neonates will be empowered to care for their high-risk neonates at home after discharge from the NICU. The app will have a simple interface that will be easy to navigate. This app will help in monitoring neonate’s growth and development, health status after discharge from the hospital, immunization status, facilitating early recognition of danger signs and prompt referral, health information on breastfeeding, expression of breast milk and feeding, kangaroo mother care, hygiene practices including bath, massage and diaper care, complementary feeding, diaper change/day. All mothers of high-risk neonates will be selected, and Randomization will be done by using computer-generated sequences. The participants will be assigned to the experimental and control groups by sequentially numbered, opaque, sealed envelopes (SNOSE method) for allocation concealment.  The pre-test will be conducted the day before discharge, and mothers will be given health education regarding home care practices for high-risk neonates using appropriate audio-visual aids. The app will be installed on the participant’s mobile, and detailed instructions on the use and benefits of the app will be given to the participants. The post-test will be conducted at one month, 3 months, and 5 months after discharge. Data will be analyzed by using specific tests like repeated-measure ANOVA, mean, and SD.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • For Neonates: High-risk neonates (Preterm infants and low birth weight infants) admitted to the NICU of a tertiary care hospital will be taken once they are hemodynamically stable and ready for discharge.
  • For mothers: Mothers of high-risk neonates who have been discharged from NICU and are willing to give consent.

排除标准

  • For mothers Mothers who cannot read and speak English or the local language, Odia.
  • Mothers who do not have smartphones Mothers who are critically ill and cannot take care of their neonates.
  • For Neonates: All term neonates All high risk neonates who can not be managed at home.

结局指标

主要结局

Maternal knowledge, satisfaction, neonatal clinical outcomes, growth and development

时间窗: one month, 3 months and 5 months

次要结局

  • Breast feeding rate, Kangaroo mother care/day, diaper change and sleep pattern of neonates(one month, 3 months and 5 months)

研究者

发起方
Siksha O Anusandhan University
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Manisha Praharaj

SOA deemed to be university

研究点 (1)

Loading locations...

相似试验

Effectiveness mHealth application on mothers... | 临床试验