Status:

COMPLETED

Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

Lead Sponsor:

Asir John Samuel

Collaborating Sponsors:

Department of Science and Technology, Government of India

Maharishi Markendeswar University (Deemed to be University)

Conditions:

Neonatal Disease

Neonatal Disorder

Eligibility:

All Genders

24-5 years

Phase:

NA

Brief Summary

To determine the effects of multisensory stimulation and soft tissue therapy on procedural pain and neurodevelopment among neonates admitted to the NICU is the aim of the study. The study will be two ...

Detailed Description

This study will utilize two parallel groups, randomised design to analyze the effects of soft tissue therapy and multisensory stimulation on pain and neurodevelopment. 104 neonates admitted in NICU wi...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • Preterm between 30- 36 weeks of gestation
  • Birth weight \>1000 g
  • Not receiving analgesics/sedatives
  • APGAR score ranged between 4-6 in 1 min. \& 7 to 9 in 5 min.
  • Undergoing routine healthcare procedures in NICU
  • Exclusion Criteria
  • Preterm with surgery
  • Preterm having unstable vitals
  • Preterm with congenital malformations
  • Preterm who require mechanical ventilation
  • Having inborn errors of metabolism and also with seizures disorders,

Exclusion

    Key Trial Info

    Start Date :

    October 22 2020

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 20 2023

    Estimated Enrollment :

    68 Patients enrolled

    Trial Details

    Trial ID

    NCT04366102

    Start Date

    October 22 2020

    End Date

    October 20 2023

    Last Update

    August 6 2024

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

    Ambāla, Haryana, India, 133207