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To ascertain the effectiveness of early physiotherapy intervention of infants born before due date and with low birth weight who are at high risk of developing motor developmental delay

The effect of early physical therapy intervention of singleton preterm very low birth weight infants at high risk of developing motor developmental delay - a randomized controlled clinical trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000227
Enrollment
200
Registered
2010-03-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Neonatal Morbidity due to decreasing gestational age and birth weight. Neurodevelopmental outcomes. Motor developmental delay.

Interventions

Intervention1: Tactile Stimulation: Massage Kangaroo Mother Care Intervention2: Proprioceptive stimulation: Passive range of motion. Positioning. Intervention3: Vestibular Stimulation: Slow rocking m
equilibruim reactions. Intervention7: Home intervention: Parents will follow the treatment protocol at home and compliance will be ensured by Social Worker. Control Intervention1: Tactile Stimulation:

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Neonatal medical index I & II Preterm: >32 weeks to Birthweight: 1000-1500gms.

Exclusion criteria

Exclusion criteria: Neonatal Medical Index III, IV & V. Birth asphyxia. Hypoxic Ischemic Encephalopathy. Meningitis, Encephalitis.

Design outcomes

Primary

MeasureTime frame
Motor domains on Developmental Assessment of Indian Infants (DASII)Timepoint: Four months (corrected age).

Secondary

MeasureTime frame
Height, Weight, Head circumference. Average length of NICU stay.Timepoint: At birth, Discharge to home from NICU, Four months (corrected age)

Countries

India

Contacts

Public ContactSelvam Ramachandran

Sikkim Manipal Institute of Medical Sciences

rs79physio@gmail.com03592270294

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026