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OpenTrials
Completed

NCT Number: NCT04247308

Multi Modal Stimulations in Pre-term Neonates

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.

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Key information

Conditions

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

Age range

2 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, 133207, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Sensory stimulation

Other

Auditory, tactile, visual, vestibular and oro motor stimulation

Movement therapy

Other

Passive range of movements, antigravity movements in prone and supine

Routine hospital care

Other

Maintaining the vitals

Primary outcomes

  1. Infant Neurological International Battery

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Asir John Samuel

Other

Collaborators

  • Maharishi Markendeswar University (Deemed to be University)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 30, 2020
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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