Multi Modal Stimulations in Pre-term Neonates

NCT ID: NCT04247308

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-12-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

experimental group

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

Group Type: EXPERIMENTAL

Sensory Stimulation

Intervention Type: OTHER

Auditory, tactile, visual, vestibular and oro motor stimulation

Movement therapy

Intervention Type: OTHER

Passive range of movements, antigravity movements in prone and supine

control group

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

Group Type: ACTIVE_COMPARATOR

Routine hospital care

Intervention Type: OTHER

Maintaining the vitals

Interventions

Sensory Stimulation

Auditory, tactile, visual, vestibular and oro motor stimulation

Intervention Type: OTHER

Movement therapy

Passive range of movements, antigravity movements in prone and supine

Intervention Type: OTHER

Routine hospital care

Maintaining the vitals

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Days
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role: collaborator

Asir John Samuel

OTHER

Sponsor Role: lead

Responsible Party

Asir John Samuel

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Vencita P Aranha, MPT, (PhD)

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Neonatal Intensive Care Unit, Maharishi Markandeshwar Hospital

Ambāla, Haryana, India

Countries

India

References

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.

Reference Type: BACKGROUND

PMID: 34719445 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34864695 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

Contains 56 Preterm Infants data which includes, gestational age, chronological age, corrected gestational age, sex, birth weight, birth length, birth occipitofrontal circumference (OFC), APGAR at 1-min, and APGAR at 5-min, pre-post intervention (5 days) changes of weight, length, OFC, INFANIB (Infant Neurological International Battery) and NIPS (Neonatal Infant Pain Scale).

View Document

Other Identifiers

U1111-1236-9478

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/1566

Identifier Type: -

Identifier Source: org_study_id