Multi Modal Stimulations in Pre-term Neonates

NCT04247308 | Completed DMC

• 2 other identifiers: MMDU/IEC/1566U1111-1236-9478
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

A total of 56 neonates with LBW will recruited by the convenience sampling to participate in this two group pre-test post-test, single blinded randomized clinical study. After the demographics, recruited NLBW will be randomly divided into two groups, group A and group B with block randomization. There will be four blocks, with the matrix design of 4X14 here 14 being rows. Each block contained 4 chits (2 chits for each group), totalling 56. The subjects will be allotted to the group based on the randomly chosen chit by their parents. Once the block will be allotted, next row block was opened. Thus, equal number of NLBW will be assigned to each group over time. Group A will be receiving multimodal sensory and kinesthetic stimulation (MSKS) and Group B will be receiving regular lifesaving hospital care. Group A will receive the interventions for 2 weeks period, totalling 10 sessions. Each session will last for 30 minutes duration.

Conditions

Preterm Birth; Infant, Premature, Diseases

Keywords

Preterm; Neonate; Multi-modal stimulation

Outcome Measures

Primary Outcomes (1)

• Infant Neurological International Battery

  Infant Neurological International Battery (INFANIB), the minimum and maximum values are 14 and 70 respectively, and higher scores mean a better outcome. Scores less than and equal to 48 is abnormal while greater than and equal to 66 means normal.

  Change from baseline and 2 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Sensory stimulations (ATVV) will be consisting of Soft lullaby between of 30-40 dB for Auditory, Gentle stroking massage in supine position(upper and lower limb)for Tactile, Visual Stimulations with Black and white card (distance of 8-10 in), gentle rocking (vertical and horizontal direction) for the stimulation of vestibular system and oral stimulation including stocking cheeks, lips, jaw and tongue, rubbing gum.Each stimulation will be given for 3 minutes. Movement therapy will include: Guided range of motion: flexion-extension movements of lower limb (bicycle riding pattern). Hand should be placed around knee joint. Care must be taken as PI consist the cartilaginous joints at wrist and ankle. Anti gravity movements in prone (neck and spinal extension), Anti gravity movements in sitting (supported) and Upright positioning for 3min each

Other: Sensory Stimulation; Other: Movement therapy

control group

ACTIVE COMPARATOR

receives routine care from the nursing team as well as daily maternal care, such as being held in the mother's arms

Other: Routine hospital care

Interventions

Sensory Stimulation OTHER

Auditory, tactile, visual, vestibular and oro motor stimulation

experimental group

Movement therapy OTHER

Passive range of movements, antigravity movements in prone and supine

experimental group

Routine hospital care OTHER

Maintaining the vitals

control group

Eligibility Criteria

• Age: 2 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born between 28 and 36 week of gestation
• Birth weight ranging from 1000-2500 g.
• Medically stable preterm infants

You may not qualify if:

• Medically unstable preterm infants.
• Infants with congenital anomalies, congenital infections and central nervous system injury

Sponsors & Collaborators

• Asir John Samuel: lead
• 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 (2)

• Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2022;15(2):229-235. doi: 10.3233/NPM-210858.

  PMID: 34719445 BACKGROUND

• Aranha VP, Chahal A, Bhardwaj AK. Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial. J Neonatal Perinatal Med. 2023;16(2):325-337. doi: 10.3233/NPM-210889.

  PMID: 34864695 RESULT

MeSH Terms

Conditions

Premature Birth; Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Vencita P Aranha, MPT, (PhD)

  Maharishi Markandeshwar Institute of physiotherapy and Rehabilitation, MM(DU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two group pre-test post-test design

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 30, 2020
• Study Start: October 1, 2020
• Primary Completion: October 30, 2021
• Study Completion: December 13, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the end of the study
• Access Criteria: Mendeley data

Locations

IN (1)