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
|
|
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
|
|
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. |