Reducing Pain and Promoting Neurodevelopment Among Preterm Neonates

NCT04366102 | Completed DMC

• 2 other identifiers: MMDU/IEC/2152U1111-1242-9663
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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 groups randomized clinical trial of five days intervention program. The intervention will be given among two groups. Group A will receive both multisensory stimulation and soft tissue therapy, Group B will receive only regular hospital care. The PIPP and N-PASS will be used for assessing pain. The INFANIB and Premie-Neuro will be used for assessing neuromotor development among neonates. The outcomes will be taken before and after the fifth day of the intervention. Multisensory stimulation and soft tissue therapy might help in reducing pain and promoting neurodevelopment.

Conditions

Neonatal Disease; Neonatal Disorder

Keywords

Neonates; Pain

Outcome Measures

Primary Outcomes (2)

• The Premature infant pain profile-Revised (PIPP-R)

  Measuring procedural pain among neonates, having 1 to 3 scoring. 0 describe normal and 3 describes low score

  Change score of PIPP at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention

• Neonatal pain agitation sedation scale (N-PASS)

  Measuring procedural pain along with sedation, having score ranged from 0 to 2, 0 describes normal and 2 describes low score

  Change score of N-PASS at the baseline(immediately after painful procedure, at 30s, 60s, 90s, and 120s) and after five days of intervention

Secondary Outcomes (2)

• Infant neurological international battery (INFANIB)

  Change score of INFANIB at the baseline and after five days of intervention

• Premie-Neuro

  Change score of Premie-Neuro at the baseline and after five days of intervention

Study Arms (2)

Group A

EXPERIMENTAL

Multisensory stimulation and soft tissue therapy

Other: Multisensory stimulation with soft tissue therapy

Group B

EXPERIMENTAL

Routine Hospital care

Other: Routine hospital care

Interventions

Multisensory stimulation with soft tissue therapy OTHER

Multisensory stimulation with soft tissue therapy will be given. Multisensory stimulation consists of Auditory, vestibular, tactile, olfactive, oromotor, Visual, and Kinesthetic stimulation. Soft tissue therapy consists of stroking, effleurage, fingertip kneading, tapping, and skin rolling will be given. Total intervention will be given for 30 min. 5 times per week

Group A

Routine hospital care OTHER

Routine hospital care will be given to the preterm neonates

Group B

Eligibility Criteria

• Age: 24 Hours - 5 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Asir John Samuel: lead
• Department of Science and Technology, Government of India: collaborator
• Maharishi Markendeswar University (Deemed to be University): collaborator

Study Sites (1)

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, 133207, India

Location

Related Publications (3)

• Zeraati H, Nasimi F, Rezaeian A, Shahinfar J, Ghorban Zade M. Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial. Iran J Child Neurol. 2018 Summer;12(3):32-39.

  PMID: 30026767 BACKGROUND

• de Melo GM, Lelis AL, de Moura AF, Cardoso MV, da Silva VM. [Pain assessment scales in newborns: integrative review]. Rev Paul Pediatr. 2014 Dec;32(4):395-402. doi: 10.1016/j.rpped.2014.04.007.

  PMID: 25511005 BACKGROUND

• Sharma N, Samuel AJ. Multisensory Stimulation and Soft Tissue Therapy on Pain and Neurodevelopment Among Preterm Neonates. Pediatr Phys Ther. 2022 Apr 1;34(2):277-282. doi: 10.1097/PEP.0000000000000887.

  PMID: 35385466 DERIVED

Related Links

• Effect of Multi-sensory Stimulation on Neuromuscular Development of Premature Infants: A Randomized Clinical Trial
• Pain assessment scales in newborns: integrative review

MeSH Terms

Conditions

Infant, Newborn, Diseases; Pain

Interventions

Therapy, Soft Tissue

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Neha Sharma, MPT

  Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Asir J Samuel, MPT, PhD

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation

  STUDY CHAIR

• Kusum Mahajan, MD

  Maharishi Markandeshwar Institute of Medical Sciences & Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Model Details: Neonates admitted in the Neonatal intensive care unit will be divided randomly into 2 groups.

Study Record Dates

• First Submitted: April 25, 2020
• First Posted: April 28, 2020
• Study Start: October 22, 2020
• Primary Completion: September 16, 2023
• Study Completion: October 20, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study Protocol - December, 2020 Statistical Analysis Plan (SAP) - December, 2020 Informed Consent Form (ICF) - December, 2020
• Access Criteria: By publishing study protocol with detailed statistical Analysis Plan in SCOPUS and PubMed indexed journals

Locations

IN (1)