Multi Modal Stimulations in Pre-term Neonates

Preterm Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04247308
• Other study ID #: MMDU/IEC/1566
• Secondary ID: U1111-1236-9478
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: January 2022
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 13, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth
• Preterm Birth

Intervention

Other:
• Sensory Stimulation
Auditory, tactile, visual, vestibular and oro motor stimulation
• Movement therapy
Passive range of movements, antigravity movements in prone and supine
• Routine hospital care
Maintaining the vitals

Locations

Country	Name	City	State
India	Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital	Ambala	Haryana

Sponsors (2)

Lead Sponsor	Collaborator
Asir John Samuel	Maharishi Markendeswar University (Deemed to be University)

Country where clinical trial is conducted

India, 

References & Publications (2)

Aranha VP, Chahal A, Bhardwaj AK. Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review. J Neonatal Perinatal Med. 2021 Oct 26. doi: 10.3233/NPM-210858. [Epub ahead of print] — View Citation

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. 2021 Nov 30. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Neonatal aquatic physiotherapy in neonatal intensive care units: A scoping review
•   Short-term effects of multimodal stimulation on neuromotor behaviour and neonatal pain among hospitalized preterm infants: A feasibility, non-blinded randomized controlled trial