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CTRI Number  CTRI/2020/09/027994 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 17/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Benefits of physiotherapy techniques and movement therapy on breathing and overall development of premature babies 
Scientific Title of Study   Effect of Neurophysiological Facilitation techniques and Movement Imitation Therapy on respiratory function and neuromotor development in preterm infants - A randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manasa K R 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions/ Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9535192550  
Fax    
Email  manasa.kolibylu@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhamini Krishna Rao 
Designation  Professor 
Affiliation  Manipal College of Health Professions/ Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480267152  
Fax    
Email  bhamini.kr@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bhamini Krishna Rao 
Designation  Professor 
Affiliation  Manipal College of Health Professions/ Manipal Academy of Higher Education 
Address  Department of Physiotherapy, Manipal College of Health Professions Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9480267152  
Fax    
Email  bhamini.kr@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions, MAHE, Manipal 
 
Primary Sponsor  
Name  Manasa K R 
Address  Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal Manipal Academy of Higher Education 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manasa K R  Kasturba Medical Hospital  Neonatal Intensive Care Unit (NICU), Department of Pediatrics and Department of Physiotherapy
Udupi
KARNATAKA 		 9535192550

manasa.kolibylu@learner.manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P220||Respiratory distress syndrome of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  1. Neurophysiological facilitation techniques along with routine medical & nursing care 2. Movement Imitation therapy with sensory stimulation  1. Neurophysiological facilitation (NPF) techniques are perioral stimulation, intercostal stretch and co-contraction of the abdomen. Duration: each technique is given for 30 seconds and followed by rest period of 30 seconds, 5 minutes per session; Four times a day with at least 2 hours of interval period and total of 20 minutes per day (till infant reaches 34 weeks of gestation). Two of the NPF techniques, i.e. Intercostal stretch and Co-contraction of the abdomen will be continued till the time of discharge. Also, parents will be trained to continue and follow up these two techniques at home after the discharge. 2. Movement Imitation therapy (MIT) is given by gently guiding the babys limbs for smooth and fluent movements, imitating the normal general movement sequences as closely as possible. Duration is at least 10 minutes, 5 times per day Parents will be trained to administer MIT post discharge till first follow-up (2-4 months). Parent educational handouts will be given for further milestone development. Log-book will be maintained (adherence to early stimulation program). 
Comparator Agent  1.Routine medical & Nursing care 2.Range of motion exercises with sensory stimulation   1.The infants assigned to this group would receive routine medical and nursing care. 2.Range of motion exercises with sensory stimulation (auditory by mother’s/ therapist voice, tactile and vestibular/proprioceptive – hammock handling(34 weeks of gestation). Duration is 5 minutes per session, twice per day and total of 10 – 15 minutes per day. Training of range of motion exercises with sensory stimulation will be given to the parents. Parents will be trained to continue these exercises after the discharge from the hospital till first follow up (3 – 4 months). Parent educational handouts will be given for further milestone development. Log-book will be maintained (adherence to early stimulation program).  
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  30.00 Day(s)
Gender  Both 
Details  1.Very preterm infants, Gestational age – 26 to 30 weeks
2.Birth weight >750 grams
3.Invasive / non-invasive modes of ventilation

Understanding of parental experience in delivering the early stimulation program-Secondary Objective
Study design: Qualitative in-depth interview
Study setting: Neonatal Intensive Care and Pediatric Physiotherapy outpatient department, Kasturba Hospital, Manipal
Subjects: Parents of preterm infants from both the groups with low, average & high scores of HINE & BSID - III
Sampling method: Purposive
Time of interview: 3 – 4 months follow up
Sample size: 12

1. Parents who are able to comprehend simple instructions
2. Has functional reading comprehension and communication in English/Kannada
3. Willing to participate 
 
ExclusionCriteria 
Details  1.Uncompensated acid-base balance
2.Bradycardia or tachycardia (<80 bpm and >180bpm)
3.Cardiac arrest survivor
4.Untreated/symptomatic congenital heart disease
5.Diaphragmatic hernia
6.Severe congenital anomalies

Understanding of parental experience in delivering the early stimulation program-Secondary Objective
Study design: Qualitative in-depth interview
Study setting: Neonatal Intensive Care and Pediatric Physiotherapy outpatient department, Kasturba Hospital, Manipal
Subjects: Parents of preterm infants from both the groups with low, average & high scores of HINE & BSID - III
Sampling method: Purposive
Time of interview: 3 – 4 months follow up
Sample size: 12

1.Parents who are not able to comprehend simple instructions
2.Not able to read and write
3.Not willing to participate

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Modified Downes score
2. Silverman Anderson score 		 Everyday, before and after the intervention during 26 to 32 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Prechtl’s General Movement Assessment (GMA)
2. Neurobehavioral assessment of the Preterm Infant (NAPI)
3. Test of Infant Motor Performance (TIMP)
4. Hammersmith Infant Neurological Examination (HINE)
5. Bayley Scale of Infant and Toddler Development – 3rd edition (BSID-III) 		 Baseline assessment using GMA, NAPI and TIMP at 32 weeks

At the time of discharge from the hospital, assessment is done using GMA, NAPI and TIMP

At 3 to 4 months follow up assessment using GMA, TIMP, HINE and BSID-III

At 6 months follow up, assessment using HINE and BSID-III 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/10/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Premature birth is a critical concern affecting newborn and maternal health, predominantly in developing countries. Respiratory morbidity is a common consequence of prematurity. The development and function of the upper body and ribcage are interrelated with the abdomen and lower body. Neurophysiological facilitation technique is the application of external proprioceptive and tactile stimuli which normalizes the rate and depth of breathing. Movement Imitation Therapy is a novel approach that involves mimicking of fluent and variable general movement sequences. This might optimize motor repertoire and neuromotor development.
Need of the study:
1. Considering the differences in respiratory system development/ orientation/ properties, preterm infants need prolonged ventilation. Promoting respiratory muscle function, better ventilation-perfusion match, and reduction in the work of breathing may facilitate early weaning from ventilation.
2. An early stimulation program with a range of motion exercises addressing a uniaxial range of movements is established among newborns. But it is important to facilitate multi-axial, variability of movements in preterm infants.
3. The altered orientation of the ribcage might affect an infant’s base of support, thereby promoting adequate muscle tone of the ribcage and extremities which may positively enhance: trunk control, self-regulation, and oral feeding skills. Hence, addressing the ribcage from birth might influence an infant’s overall neuromotor development. 
Objectives of the study:
Primary objectives
1. To study the effect of Neurophysiological Facilitation techniques on respiratory function in preterm infants of 26 - 30 weeks of gestation.
2. To determine the effect of Neurophysiological Facilitation techniques on non-invasive modes of ventilation 
Secondary objectives
1. To study the effect of Movement Imitation Therapy on neuromotor and neurobehavior function in preterm infants when attained 34 weeks of gestation.
2. To understand the parental experience in delivering the two different early stimulation programs during follow up at 6 months of age.
Hypothesis and Importance of the Study: 
1. If the Neurophysiological facilitation (NPF) technique is found to be an effective intervention, it might reduce the number of days of hospitalization (cost-effective) and thus the burden of the parents.
2. If minimal intervention like Movement Imitation therapy (MIT) is administered by the parents, it might reduce the infant’s exercise energy expenditure and promote coordinated stability and mobility of the ribcage and extremities.
3. A combination of NPF and MIT might prevent the occurrence of ribcage irregularities, supports respiratory function, and promote optimal neuromotor development among preterm infants.
4. Understanding parental experience of delivering early stimulation program can be a value addition for structuring or designing the early stimulation program.
 
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