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CTRI Number  CTRI/2016/07/007070 [Registered on: 11/07/2016] Trial Registered Retrospectively
Last Modified On: 04/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of physiotherapy exercises on brain development of pretem newborn babies  
Scientific Title of Study   Effect of structured neonatal physiotherapy intervention on neuromotor development of moderate to late preterm infants  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonia Khurana 
Designation  PhD Scholar 
Affiliation  School of Allied Health Sciences, Manipal University, Manipal 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902351868  
Fax    
Email  soniakhurana84@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhamini Krishna Rao  
Designation  Professor and Head 
Affiliation  Professor and Head 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal
Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal
Udupi
KARNATAKA
576104
India 
Phone  919480267152  
Fax    
Email  bhaminikr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sonia Khurana 
Designation  PhD Scholar 
Affiliation  School of Allied Health Sciences, Manipal University, Manipal 
Address  Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9902351868  
Fax    
Email  soniakhurana84@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  School of Allied Health Sciences 
Address  Manipal Madhav Nagar Karnataka- 576104 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Sonia Khurana  Department of Physiotherapy, School of Allied Health Sciences, Manipal University, Manipal Karnataka - 576104 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Leslie Edward Lewis  Kasturba Medical College and Hospital  Neonatal Intensive Care Unit, Department of Paediatrics, Kasturba Medical College & Hospital, Manipal University, Manipal
Udupi
KARNATAKA 
919449208476

leslie.lewis@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital , Manipal Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Healthy Human Volunteers  Preterm Infants born between 32 week 0 days of gestation to 36 week 6 days of gestation  
Patients  (1) ICD-10 Condition: P073||Preterm [premature] newborn [other],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison Outcome measures  At discharge from the hospital neurobehavioral and neuromotor performance will be evaluated for control and intervention group using outcome measure Neurobehavioral assessment of preterm infants and Prechtls general movement analysis. At 3 month and 6 month neuromotor and cognitive status will be evaluated for control and intervention group using outcome measure Prechtls general movement analysis and bayley scale of infant and toddler development. 
Intervention  Control Group Routine medical and nursing care  Infants in control group will continue to receive routine medical and nursing care which consists of traditional massage and positioning. 
Intervention  Intervention Group  Intervention group will undergo treatment according to recommendations of American Physical Therapy Association. The treatment includes positioning, Range of motion exercise, Joint compressions, self calming and midline activities, Massage, Visual stimulation, Vestibular stimulation and music therapy using Indian Classical music. 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Medically stable preterm neonates admitted to Kasturba hospital and born between 32weeks 0 day – 36 weeks 6 days of gestational age 
 
ExclusionCriteria 
Details  •Requirement of oxygen and ventilation at 36 weeks gestational age
•Infants with genetic/chromosomal disorders
•Congenital anomalies.
•Significant neurological/musculoskeletal insult during follow up period ( from time of discharge to 6 months of age)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Neurobehavior and neuromotor development of preterm infant using Neurobehavioral Assesment of Preterm Infant scale (NAPI) and Prechtls method of Qualitative asessment of General movements in preterm and term infants  At baseline and discharge from the hospital 
 
Secondary Outcome  
Outcome  TimePoints 
Neuromotor and cognitive status using Prechtls method of qualitative analysis of General movements and Bayley Scale of Infant& Toddler Development - 3rd Edition (BSID -III)  3 month and 6 month of age 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/04/2014 
Date of Study Completion (India) 15/04/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
2 Publications 1.Khurana S Neurobehavioral profile of moderate to late preterm infants admitted in a tertiary care centre in South India. Online Journal of Health and Allied Sciences 2016 2. Khurana S Development and validation of educational leaflet for caregivers of preterm infants. Journal of Clinical and Diagnostic Research 2016 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

According to World Health Organisation, 85% of the total preterm births belong to moderate to late preterm category worldwide. India is at the top of the list with number estimated to be 2,959,300 per year. Moderate to late preterm infants were believed to have fewer problems postnatally and were considered equivalent to their term counterparts. Hence they were always managed with routine newborn care and never received the type of attention they deserved. Literature has documented the risks and morbidities of this group.  Thus care should be targeted towards managing their physiological stability and ensuring proper neurodevelopment. There is very limited data about the early intervention care provided by neonatal physiotherapists in NICU. Early intervention is an umbrella term for Positioning, swaddling, range of motion, massage, auditory, tactile, visual,vestibular and oromotor stimulation. These interventions are aimed at providing the modulated and paced sensory motor experience to protect the maturation and architecture of infant’s brain. Most of the literature is available on gestation less than 32 weeks and moreover from the western nations. The obstetric and newborn care practised in these countries is quite different from a developing country like India. Thus there is an immense need to conduct a study, which will deal with all the problems of moderate to late preterm infants. Keeping these areas into consideration, a study has been planned which aims at application of structured neonatal physiotherapy recommendations provided by American Physical Therapy association and its effects on the neurodevelopment of moderate to late preterm infants.

 Potential preterm infants admitted to Kasturba Hospital NICU between 32 weeks 0 day – 36 weeks 6 days of gestation will be screened for inclusion criteria and will be included in the study. Study procedures will be explained in detail to the parents and written informed consent will be obtained from them. Demographic details of infants will be collected. Baseline assessment will be done using NAPI and Prechtl’s videographic Method on the Qualitative Assessment of General Movements in Preterm, Term and Young Infants. After baseline assessment, the infant will be randomly allocated to either control group or intervention group using block randomisation. Following randomisation, intervention will be performed. The infants assigned to the control group will continue to receive the routine medical and nursing care consisting of traditional positioning, traditional massage. Participants in the intervention group will receive structured neonatal physiotherapy intervention from 32 weeks till discharge designed by American Physical Therapy Association. At the time of discharge, infant both in control as well as intervention group will be evaluated for neuromotor status again using Prechtl’s and NAPI scale. Parents will be provided with pamphlets of home program.  Home program pamphlets will contain description regarding stimulation techniques and facilitation of age appropriate milestones for 0-3 month and 4- 6 month. Compliance will be maintained through log book and regular phone calls. Reminder calls will be given for 3 month and 6 month follow up.  At 3 month follow up visit, assessment for general movement will be done using Prechtl’s Method and neuromotor development will be evaluated using (BSID- III). At 6 month follow up visit, final neuromotor development will be assessed using BSID –III and results will be compared between control group and treatment group. Children with developmental delay if any will be identified and their parents will be advised to come for regular physiotherapy treatment in Paediatric Physiotherapy Department, Kasturba Hospital, Manipal.

This study will help us to prove the efficacy of structured Neonatal physiotherapy intervention which later on can be incorporated as a routine standard care for moderate to late preterm infant admitted in level III NICU. It will also help us in early identification of infants at risk of developmental delay in the follow up period.

 
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