Multi Modal Stimulations in Pre-term Neonates

Multi-modal Stimulations on Neuromotor Responses Among the Hospitalised Preterm Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04247308

Enrollment

Registered

2020-01-30

Start date

2020-10-01

Completion date

2021-12-13

Last updated

2022-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Premature, Diseases, Preterm Birth

Keywords

Preterm, Neonate, Multi-modal stimulation

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.

Interventions

OTHERSensory Stimulation

Auditory, tactile, visual, vestibular and oro motor stimulation

OTHERMovement therapy

Passive range of movements, antigravity movements in prone and supine

OTHERRoutine hospital care

Maintaining the vitals

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Intervention model description

Two group pre-test post-test design

Eligibility

Sex/Gender

ALL

Age

2 Days to 28 Days

Healthy volunteers

Inclusion criteria

1. Infants born between 28 and 36 week of gestation 2. Birth weight ranging from 1000-2500 g. 3. Medically stable preterm infants

Exclusion criteria

1. Medically unstable preterm infants. 2. Infants with congenital anomalies, congenital infections and central nervous system injury

Design outcomes

Primary

Measure	Time frame	Description
Infant Neurological International Battery	Change from baseline and 2 weeks	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.

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026